A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.

NCT ID: NCT00474955

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-06-30

Brief Summary

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterferon Alpha-2a

Eligible participants will be administered peginterferon alpha-2a \[Pegasys\] (40 kilo Dalton), 180 micrograms as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate of \<15 milliliter /minute will be administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.

Group Type: EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type: DRUG

180 micrograms or 135 micrograms sc weekly for 48 weeks

Interventions

peginterferon alfa-2a [Pegasys]

180 micrograms or 135 micrograms sc weekly for 48 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adult patients, 18-60 years of age;
• chronic hepatitis C;
• chronic renal failure, including patients on hemodialysis therapy;
• detectable HCV RNA levels (>500IU/mL).

Exclusion Criteria

• concurrent active hepatitis A or B;
• history or evidence of a medical condition associated with chronic liver disease other than HCV;
• history or other evidence of decompensated liver disease;
• therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months prior to study;
• acute renal failure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Chita, , Russia

Irkutsk, , Russia

Khabarovsk, , Russia

Khabarovsk, , Russia

Orenburg, , Russia

Countries

Russia

Other Identifiers

ML20434

Identifier Type: -

Identifier Source: org_study_id