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

NCT00474955 | Completed Phase 4 Results

• 1 other identifier: ML20434
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion

  Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (\<50 international units \[IU\]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).

  At Week 72

• Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48

  HCV RNA level less than 50 IU/mL was considered to be undetectable.

  At Week 24 and Week 48

• Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline

  The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit \[Days -30 to -1\]).

  From Baseline (Days -30 to -1) and Week 24

Secondary Outcomes (5)

• Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events

  Up to Week 72

• Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks

  Up to Week 48

• Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks

  Up to Week 72

• Mean Change From Baseline in Blood Pressure up to Week 72

  From Baseline (Days -30 to -1) to Week 72

• Mean Change From Baseline in Heart Rate up to Week 72

  From Baseline (Days -30 to -1) to Week 72

Study Arms (1)

Peginterferon Alpha-2a

EXPERIMENTAL

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.

Drug: peginterferon alfa-2a [Pegasys]

Interventions

peginterferon alfa-2a [Pegasys] DRUG

180 micrograms or 135 micrograms sc weekly for 48 weeks

Peginterferon Alpha-2a

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Unknown Facility

Chita, 672090, Russia

Location

Unknown Facility

Irkutsk, 664047, Russia

Location

Unknown Facility

Khabarovsk, 680009, Russia

Location

Unknown Facility

Khabarovsk, 680022, Russia

Location

Unknown Facility

Orenburg, 460040, Russia

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

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

Results Point of Contact

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

global.trial_information@roche.com

+41 616878333

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 25, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-06

Locations

RU (5)