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.

NCT00087594 | Completed Phase 4 Results

• 1 other identifier: ML17251
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Completion Rate (TCR)

  TCR is defined as the number of participants who completed the prescribed duration of the study treatment. TCR for G1 participants is defined as the number of participants who had a missing value or \>= 2-log10 decrease in Hepatitis C virus-ribonucleic acid (HCV RNA) at Week 12 and completed 48 weeks of study treatment or had a \< 2-log10 decrease from baseline at Week 12 and completed at least 12 weeks of study treatment. TCR for G2/ 3 participants is defined as the number of participants who completed 24 weeks of study treatment.

  Up to 24 weeks for G2/3; up to 48 weeks for G1

Secondary Outcomes (13)

• Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)

  Week 48 for G2/3 and Week 72 for G1

• Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion

  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)

• 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

  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)

• Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12

  Week 12

• Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)

  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).

Study Arms (2)

Direct Observed Therapy

EXPERIMENTAL

Participants will receive the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.

Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin

Self-Administration Therapy

EXPERIMENTAL

Participants will receive the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.

Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin

Interventions

peginterferon alfa-2a [Pegasys] DRUG

180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1)

Direct Observed Therapy; Self-Administration Therapy

ribavirin DRUG

1000/1200mg (\< or \>= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)

Direct Observed Therapy; Self-Administration Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

San Francisco, California, 94121, United States

Location

Unknown Facility

Farmington, Connecticut, 06030, United States

Location

Unknown Facility

Honolulu, Hawaii, 96813, United States

Location

Unknown Facility

Downers Grove, Illinois, 60515, United States

Location

Unknown Facility

Baltimore, Maryland, 21205, United States

Location

Unknown Facility

New York, New York, 10003, United States

Location

Unknown Facility

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2004
• First Posted: July 14, 2004
• Study Start: November 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: March 4, 2016
• Results First Posted: March 4, 2016

Record last verified: 2016-02

Locations

US (7)