Clinical trial NCT00087594: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.
Official title: An Open-Label, Multi-Center, Randomized, Safety, Feasibility and Tolerability Pilot Study of Pegasys® (Peginterferon Alfa-2a) Plus Copegus® (Ribavirin) in Previous Intravenous Drug Users Who Are Currently Enrolled in a Methadone Maintenance Treatment Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-07-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients at least 18 years of age
* CHC infection, genotype 1, 2, or 3
* naive to treatment for CHC infection
* enrolled in a methadone maintenance program with documented attendance for at least 3 months
* use of 2 forms of contraception during the study on both men and women

Exclusion Criteria:

* previous treatment for CHC infection
* co-infection with human immunodeficiency virus (HIV)
* current use of IV or other illicit drugs
* decompensated cirrhosis
* women who are pregnant or breastfeeding

Primary outcomes:
measure: Number of Participants With Treatment Completion Rate (TCR)
timeFrame: Up to 24 weeks for G2/3; up to 48 weeks for G1
Secondary outcomes:
measure: Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)
timeFrame: Week 48 for G2/3 and Week 72 for G1
measure: Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion
timeFrame: Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)
measure: Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion
timeFrame: Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)
measure: Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12
timeFrame: Week 12
measure: Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)
timeFrame: Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1).
measure: Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits
timeFrame: Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1)
measure: Number of Participants With Degrees of Depression as Defined by the BDI-II Score
timeFrame: Up to Week 72
measure: Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit
timeFrame: Baseline (Day -30 to -1), 24 weeks after EOT visit (Week 48 for G2/3 and Week 72 for G1)
measure: Number of Participants With Compliance to the Prescribed Treatment Regimen
timeFrame: Up to Week 24 for G 2/3; up to Week 48 for G1
measure: Number of Participants With Abnormal Vital Signs
timeFrame: Up to 24 weeks of treatment-free follow-up visit (Week 48 for G2/3 and Week 72 for G1)
measure: Number of Participants With Marked Laboratory Abnormalities (Hematology)
timeFrame: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)
measure: Number of Participants With Marked Laboratory Abnormalities (Biochemistry)
timeFrame: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)
measure: Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation
timeFrame: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Honolulu
country: United States
state: Hawaii
city: Downers Grove
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: New York
country: United States
state: New York
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: