Trial Outcomes & Findings for A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) (NCT NCT01429792)
NCT ID: NCT01429792
Last Updated: 2018-10-23
Results Overview
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
COMPLETED
PHASE4
1013 participants
Week 12
2018-10-23
Participant Flow
Male and female participants, 18 years of age and above with serologically proven genotype 1, 2, 3 or 4 CHC and treated with the standard combination treatment of peginterferon alfa-2a (Pegasys) and ribavirin (Copegus).
A total of 1013 participants were enrolled in the study and 607 of them completed the study.
Participant milestones
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Overall Study
STARTED
|
1013
|
|
Overall Study
Genotype 1
|
687
|
|
Overall Study
Genotype 2 & 3
|
305
|
|
Overall Study
Genotype 4
|
5
|
|
Overall Study
COMPLETED
|
607
|
|
Overall Study
NOT COMPLETED
|
406
|
Reasons for withdrawal
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Overall Study
Other Reasons
|
67
|
|
Overall Study
Unknown Disposition
|
94
|
|
Overall Study
Negative HCV-RNA at Week 4
|
1
|
|
Overall Study
Negative HCV-RNA at Week 12
|
4
|
|
Overall Study
Decrease of less than 2-log in HCV RNA
|
32
|
|
Overall Study
Positive HCV-RNA at Week 24
|
50
|
|
Overall Study
Withdrawal by Subject
|
70
|
|
Overall Study
Lost to Follow-up
|
88
|
Baseline Characteristics
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Baseline characteristics by cohort
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
n=1013 Participants
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Age, Continuous
|
43.6 Years
STANDARD_DEVIATION 11.3 • n=39 Participants
|
|
Sex/Gender, Customized
Female
|
380 Participants
n=39 Participants
|
|
Sex/Gender, Customized
Male
|
632 Participants
n=39 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Participants with CHC Genotype 1 \& 4 at week 12
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Outcome measures
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
n=692 Participants
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
|
15.7 Percentage of participants
Interval 12.6 to 18.1
|
PRIMARY outcome
Timeframe: Week 12Population: Participants with CHC Genotype 1 \& 4 at Week 12
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
Outcome measures
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
n=692 Participants
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
|
50.8 Percentage of participants
Interval 46.8 to 54.4
|
PRIMARY outcome
Timeframe: Week 24Population: Participants with CHC Genotype 1 \& 4 at Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment
Outcome measures
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
n=456 Participants
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
|
15.6 Percentage of participants
Interval 12.9 to 19.2
|
PRIMARY outcome
Timeframe: Week 4Population: Participants with CHC Genotype 2 \& 3 at Week 4
The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
Outcome measures
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
n=304 Participants
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
|
48.03 Percentage of participants
Interval 42.3 to 53.6
|
PRIMARY outcome
Timeframe: Week 4Population: Participants with CHC Genotype 2 \& 3 at Week 4
The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
Outcome measures
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
n=304 Participants
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
|
51.97 Percentage of participants
Interval 46.2 to 57.6
|
PRIMARY outcome
Timeframe: Week 24Population: Participants with CHC Genotype 2 \& 3 at Week 24
The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.
Outcome measures
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
n=305 Participants
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
|
6.9 Percentage of participants
Interval 4.3 to 10.3
|
SECONDARY outcome
Timeframe: Week 12Population: As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4.
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4.
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Population: As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4.
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.
Outcome measures
Outcome data not reported
Adverse Events
Pegylated Interferon Alfa 2a (Peginterferon)
Serious adverse events
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
n=1013 participants at risk
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.79%
8/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Blood and lymphatic system disorders
Haemolytic anemia
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.30%
3/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
2/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Cardiac disorders
Atrial fibrillation
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Eye disorders
Optic nerve disorder
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Eye disorders
Optic Neuropathy
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Eye disorders
Retinal haemorrhage
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Eye disorders
Uveitis
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Gastrointestinal disorders
pancreatitis
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
General disorders
Chest pain
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
General disorders
Oedema Peripheral
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
General disorders
Pyrexia
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
General disorders
Asthenia
|
0.20%
2/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Infections and infestations
Abdominal wall abcess
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Infections and infestations
Appendicitis
|
0.20%
2/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Infections and infestations
Cellulitis
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Infections and infestations
Pneumonia
|
0.30%
3/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Infections and infestations
Infection
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Infections and infestations
Tubo-ovarian abcess
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Infections and infestations
Urinary tract infection
|
0.30%
3/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Investigations
Hepatic enzyme increased
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Nervous system disorders
Polyneuropathy
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Psychiatric disorders
Major depression
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Surgical and medical procedures
Anal spincterotomy
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Surgical and medical procedures
Hernia repair
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Surgical and medical procedures
Sigmoidectomy
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Vascular disorders
Post thrombotic syndrome
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Vascular disorders
Raynaud's phenomenon
|
0.10%
1/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
Other adverse events
| Measure |
Pegylated Interferon Alfa 2a (Peginterferon)
n=1013 participants at risk
Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.2%
103/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
57/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
|
General disorders
Asthenia
|
10.2%
103/1013 • Baseline to Week 24
Safety population includes all enrolled participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER