Trial Outcomes & Findings for Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED) (NCT NCT00687544)
NCT ID: NCT00687544
Last Updated: 2017-04-06
Results Overview
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid \[HCV-RNA\] \<800,000 IU/mL was 24 weeks. SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72). The study was terminated due to low enrollment. This analysis was not performed.
TERMINATED
PHASE4
11 participants
Week 48 or Week 72 (depending on duration of treatment)
2017-04-06
Participant Flow
Participant milestones
| Measure |
PEG-IFN + RBV
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)
Baseline characteristics by cohort
| Measure |
PEG-IFN + RBV
n=11 Participants
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
Indonesia
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 48 or Week 72 (depending on duration of treatment)Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid \[HCV-RNA\] \<800,000 IU/mL was 24 weeks. SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72). The study was terminated due to low enrollment. This analysis was not performed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid \[HCV-RNA\] \<800,000 IU/mL was 24 weeks. The study was terminated due to low enrollment. This analysis was not performed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid \[HCV-RNA\] \<800,000 IU/mL was 24 weeks. SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72). The study was terminated due to low enrollment. This analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout the study (up to 72 weeks)The study was terminated due to low enrollment. This analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout the study (up to 72 weeks)Outcome measures
| Measure |
PEG-IFN + RBV
n=11 Participants
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
|
|---|---|
|
Number of Participants Who Died
|
0 participants
|
SECONDARY outcome
Timeframe: Throughout the study (up to 72 weeks)An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment.
Outcome measures
| Measure |
PEG-IFN + RBV
n=11 Participants
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
|
|---|---|
|
Number of Participants Experiencing Adverse Events
|
10 participants
|
Adverse Events
PEG-IFN + RBV
Serious adverse events
| Measure |
PEG-IFN + RBV
n=11 participants at risk
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
Other adverse events
| Measure |
PEG-IFN + RBV
n=11 participants at risk
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.2%
2/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Eye disorders
Asthenopia
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Gastrointestinal disorders
Gastritis
|
54.5%
6/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
General disorders
Influenza like illness
|
63.6%
7/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
General disorders
Fatigue
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Infections and infestations
Skin infection
|
18.2%
2/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Infections and infestations
Gastroenteritis
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Psychiatric disorders
Depression
|
18.2%
2/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Psychiatric disorders
Anxiety
|
18.2%
2/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
9.1%
1/11
There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator agrees not to publish/present any interim results without sponsor's prior written consent and agrees to provide sponsor 45 days written notice prior to submission for publication/presentation to permit the sponsor to review copies. The sponsor shall have the right to review and comment, including editing.
- Publication restrictions are in place
Restriction type: OTHER