A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

NCT01853254 | Completed Phase 3 Results

• 1 other identifier: NV17590
• Study Type: interventional
• Target: 272
• Locations: 11 countries
• Sites: 67

Brief Summary

This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least 1 Adverse Event

  From Baseline to the end of the study (up to 72 weeks)

Study Arms (1)

Peginterferon alfa-2a monotherapy or combined with ribavirin

EXPERIMENTAL

The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.

Drug: Peginterferon alfa-2a; Drug: Ribavirin

Interventions

Peginterferon alfa-2a DRUG

Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.

Also known as: Pegasys

Peginterferon alfa-2a monotherapy or combined with ribavirin

Ribavirin DRUG

For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing \< 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.

Also known as: Copegus

Peginterferon alfa-2a monotherapy or combined with ribavirin

Eligibility Criteria

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

You may qualify if:

• Adult patients, ≥ 18 years of age.
• Chronic hepatitis C.
• Compensated liver disease (Child-Pugh Class A).
• Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
• Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
• Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
• For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
• Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.

You may not qualify if:

• Pregnant or breastfeeding women.
• Male partners of women who are pregnant.
• Patients with hemoglobinopathies.
• Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
• Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
• Liver disease other than chronic hepatitis C, including hepatic carcinoma.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (67)

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Birmingham, Alabama, 35295-0005, United States

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La Jolla, California, 92037-1030, United States

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Long Beach, California, 90822, United States

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San Diego, California, 92123, United States

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San Diego, California, 92154, United States

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San Francisco, California, 94115, United States

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Aurora, Colorado, 80045, United States

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Gainesville, Florida, 32610-0214, United States

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Gainesville, Florida, 32610, United States

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Jacksonville, Florida, 32209, United States

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Miami, Florida, 33136-1051, United States

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Orlando, Florida, 32803, United States

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Orlando, Florida, 32809, United States

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Sarasota, Florida, 34243, United States

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Wellington, Florida, 33414, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30309, United States

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Marietta, Georgia, 30060, United States

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Honolulu, Hawaii, 96817, United States

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Boise, Idaho, 83702, United States

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Indianapolis, Indiana, 46202, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Baltimore, Maryland, 21205, United States

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Framingham, Massachusetts, 01702, United States

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Worcester, Massachusetts, 01655, United States

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Plymouth, Minnesota, 55446, United States

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Newark, New Jersey, 07102, United States

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Vineland, New Jersey, 08360, United States

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Binghamton, New York, 13903, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10016, United States

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New York, New York, 10021, United States

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Poughkeepsie, New York, 12601, United States

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Durham, North Carolina, 27710, United States

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Statesville, North Carolina, 28677, United States

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Cleveland, Ohio, 44106, United States

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Portland, Oregon, 97201, United States

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Lancaster, Pennsylvania, 17604-3200, United States

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Philadelphia, Pennsylvania, 19104, United States

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Providence, Rhode Island, 02905, United States

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Germantown, Tennessee, 38138, United States

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Dallas, Texas, 75203, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78215, United States

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Charlottesville, Virginia, 22906-0013, United States

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Bellevue, Washington, 98004, United States

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Seattle, Washington, 98133, United States

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Tacoma, Washington, 98403, United States

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Adelaide, 5000, Australia

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Herston, 4006, Australia

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Ribeirão Preto, 14049-900, Brazil

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Salvador, 40150-130, Brazil

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São Paulo, 01246-000, Brazil

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São Paulo, 1323020, Brazil

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Vandœuvre-lès-Nancy, 54511, France

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Thessaloniki, 56429, Greece

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Bergamo, 24128, Italy

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Napoli, 80131, Italy

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Warsaw, 01-201, Poland

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Ponce, 00716, Puerto Rico

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San Juan, 00921-3200, Puerto Rico

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San Juan, 00936-5067, Puerto Rico

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Santurce, 00909, Puerto Rico

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Barcelona, 08803, Spain

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Taoyuan District, 333, Taiwan

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Plymouth, PL6 8DH, United Kingdom

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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: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 14, 2013
• Study Start: September 1, 2003
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 4, 2013
• Results First Posted: September 4, 2013

Record last verified: 2013-06

Locations

PR (4); ES (1); AU (2); PL (1); FR (1); GR (1); GB (1); BR (4); IT (2); TW (1); US (49)