Trial Outcomes & Findings for Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy (NCT NCT02060058)

Results Overview

The methods used to assess this outcome measure is by full-analysis set (FAS), which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of any antiviral medication (Boceprevir/peginterferon/ribavirin)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

12 participants

Primary outcome timeframe

week 24

Results posted on

2018-03-13

Participant Flow

As protocol

Participant milestones

Participant milestones
Measure	Patients With 32 Week Therapy For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.	Null Responder or Cirrhotic Patients For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
Overall Study STARTED	4	8
Overall Study COMPLETED	4	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With 32 Week Therapy n=4 Participants For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.	Patients With 48 Weeks Therapy For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.	Null Responder or Cirrhotic Patients n=8 Participants For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.	Total n=12 Participants Total of all reporting groups
Age, Continuous	42.9 years STANDARD_DEVIATION 16.0 • n=99 Participants	—	50.6 years STANDARD_DEVIATION 9.2 • n=206 Participants	48.0 years STANDARD_DEVIATION 11.7 • n=7 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	—	4 Participants n=206 Participants	4 Participants n=7 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	—	4 Participants n=206 Participants	8 Participants n=7 Participants

PRIMARY outcome

Timeframe: week 24

Population: For survey the total 12 chronic hepatitis C patients by FAS in different arms in this clinical- trial. Outcome Measure Data Table: For survey the total 8 chronic hepatitis C patients had SVR by FAS in different arms in this clinical- trial.

The methods used to assess this outcome measure is by full-analysis set (FAS), which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of any antiviral medication (Boceprevir/peginterferon/ribavirin)

Outcome measures

Outcome measures
Measure	Patients With 32 Week Therapy n=4 Participants For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.	Patients With 48 Weeks Therapy For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.	Null Responder or Cirrhotic Patients n=8 Participants For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48. Stop trial intervention for boceprevir, PEG-IFN and RBV: Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
Number of Full Analysis Set Participants Who Received HCV Anti-viral Therapy With Sustained Virological Response (SVR)	4 participants	—	4 participants

SECONDARY outcome

Timeframe: week 24

Population: MITT population included subjects receiving ≥ 1 dose of boceprevir.

The total 7 patients had SVR by mITT in this clincial-trial, which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of Boceprevir

Outcome measures

Outcome measures
Measure	Patients With 32 Week Therapy n=4 Participants For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.	Patients With 48 Weeks Therapy For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.	Null Responder or Cirrhotic Patients n=7 Participants For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48. Stop trial intervention for boceprevir, PEG-IFN and RBV: Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
Key Secondary Endpoint of This Clinical Trial-SVR in mITT	4 participants	—	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 24

HBV virologic response, defined as serum HBV DNA levels to \< 200 IU/mL at follow-up week 24 among patients with detectable HBV DNA at baseline

Outcome measures

Outcome measures
Measure	Patients With 32 Week Therapy n=4 Participants For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.	Patients With 48 Weeks Therapy For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.	Null Responder or Cirrhotic Patients n=8 Participants For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48. Stop trial intervention for boceprevir, PEG-IFN and RBV: Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
The Other Responses in the mITT Population/Safty- HBV Virologic Response	0 participants	—	0 participants

Adverse Events

Patients With 32 Week Therapy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Patients With 48 Weeks Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Null Responder or Cirrhotic Patients

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With 32 Week Therapy n=4 participants at risk For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.	Patients With 48 Weeks Therapy For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.	Null Responder or Cirrhotic Patients n=8 participants at risk For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
Pregnancy, puerperium and perinatal conditions pregnancy	0.00% 0/4 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.	— 0/0 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.	12.5% 1/8 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.
Infections and infestations Fever	0.00% 0/4 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.	— 0/0 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.	0.00% 0/8 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.

Other adverse events

Other adverse events
Measure	Patients With 32 Week Therapy n=4 participants at risk For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.	Patients With 48 Weeks Therapy For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.	Null Responder or Cirrhotic Patients n=8 participants at risk For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
Gastrointestinal disorders Gastroenterology	100.0% 4/4 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.	— 0/0 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.	100.0% 8/8 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.
Skin and subcutaneous tissue disorders Dermatology	75.0% 3/4 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.	— 0/0 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.	87.5% 7/8 • The specific period of time over which adverse event data were collected from baseline to end of follow up. Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.

Additional Information

Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine

Kaohsiung Medical University Hospital

Phone: +886-7-3121101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place