A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

peginterferon alfa-2a

rivavirin

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL)) elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening liver biopsy findings consistent with a diagnosis of chronic hepatitis C. Exclusion Criteria: Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter) leukopenia (fewer than 3,000 white blood cells per cubic millimeter) thrombocytopenia (fewer than 90,000 platelets per cubic millimeter) anemia (less than 12 g hemoglobin per deciliter ) hepatitis B co-infection decompensated liver disease organ transplant creatinine clearance less than 50 milliliters per minute poorly controlled psychiatric disease poorly controlled diabetes malignant neoplastic disease severe cardiac or chronic pulmonary disease immunologically mediated disease retinopathy.

Sites / Locations

Outcomes

Primary Outcome Measures

Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).

Secondary Outcome Measures

Biochemical response (normalization of serum alanine aminotransferase activity),

Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.

Full Information

NCT ID

NCT00144469

First Posted

September 2, 2005

Last Updated

January 29, 2009

Sponsor

Chugai Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00144469

Brief Title

A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C

Official Title

A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

May 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chugai Pharmaceutical

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy. Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.

Detailed Description

Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo. All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a

Intervention Type

Drug

Intervention Name(s)

rivavirin

Primary Outcome Measure Information:

Title

Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).

Secondary Outcome Measure Information:

Title

Biochemical response (normalization of serum alanine aminotransferase activity),

Title

Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL)) elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening liver biopsy findings consistent with a diagnosis of chronic hepatitis C. Exclusion Criteria: Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter) leukopenia (fewer than 3,000 white blood cells per cubic millimeter) thrombocytopenia (fewer than 90,000 platelets per cubic millimeter) anemia (less than 12 g hemoglobin per deciliter ) hepatitis B co-infection decompensated liver disease organ transplant creatinine clearance less than 50 milliliters per minute poorly controlled psychiatric disease poorly controlled diabetes malignant neoplastic disease severe cardiac or chronic pulmonary disease immunologically mediated disease retinopathy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hirokazu Furuta

Organizational Affiliation

Chugai Pharmaceutical

Official's Role

Study Director

Chronic Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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