A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

December 11, 2015 updated by: Hoffmann-La Roche

Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6661

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation, 163000
      • Barnaul, Russian Federation, 656045
      • Barnaul, Russian Federation, 656010
      • Blagoveshchensk, Russian Federation, 675007
      • Cheboksary, Russian Federation, 428016
      • Chelyabinsk, Russian Federation, 454048
      • Chelyabinsk, Russian Federation, 454052
      • Chelyabinsk, Russian Federation, 454071
      • Cherepovets, Russian Federation, 162600
      • Chita, Russian Federation, 672090
      • Ekaterinburg, Russian Federation, 620020
      • Ekaterinburg, Russian Federation, 620042
      • Ekaterinburg, Russian Federation, 620102
      • Irkutsk, Russian Federation, 664043
      • Irkutsk, Russian Federation, 664047
      • Irkutsk, Russian Federation, 664079
      • Izhevsk, Russian Federation, 426067
      • Kazan, Russian Federation, 420097
      • Kemerovo, Russian Federation, 650099
      • Kemerovo, Russian Federation, 650000
      • Kemerovo, Russian Federation, 650036
      • Khabarovsk, Russian Federation, 680009
      • Khabarovsk, Russian Federation, 680022
      • Khabarovsk, Russian Federation, 680031
      • Kirov, Russian Federation, 610000
      • Krasnodar, Russian Federation, 350015
      • Krasnodar, Russian Federation, 350012
      • Krasnodar, Russian Federation, 350086
      • Krasnoyarsk, Russian Federation, 660022
      • Krasnoyarsk, Russian Federation, 660049
      • Lipetsk, Russian Federation, 398043
      • Makhachkala, Russian Federation, 367008
      • Moscow, Russian Federation, 143420
      • Moscow, Russian Federation
      • Moscow, Russian Federation, 115446
      • Moscow, Russian Federation, 125367
      • Moscow, Russian Federation, 103875
      • Moscow, Russian Federation, 105203
      • Moscow, Russian Federation, 109325
      • Moscow, Russian Federation, 111020
      • Moscow, Russian Federation, 111123
      • Moscow, Russian Federation, 115201
      • Moscow, Russian Federation, 115516
      • Moscow, Russian Federation, 115682
      • Moscow, Russian Federation, 119002
      • Moscow, Russian Federation, 119881
      • Moscow, Russian Federation, 121293
      • Moscow, Russian Federation, 123098
      • Moscow, Russian Federation, 123367
      • Moscow, Russian Federation, 125101
      • Moscow, Russian Federation, 127247
      • Moscow, Russian Federation, 129110
      • Nizhny Novgorod, Russian Federation, 603022
      • Novokuznetsk, Russian Federation, 654018
      • Novokuznetsk, Russian Federation, 654029
      • Novosibirsk, Russian Federation, 630016
      • Novouralsk, Russian Federation, 624130
      • Omsk, Russian Federation, 644010
      • Orenburg, Russian Federation, 460035
      • Petropavlovsk-Kamchatskiy, Russian Federation, 683003
      • Rostov-na-donu, Russian Federation, 344022
      • Salekhard, Russian Federation, 629001
      • Samara, Russian Federation, 443011
      • Samara, Russian Federation, 443021
      • Saratov, Russian Federation, 410026
      • Saratov, Russian Federation, 410028
      • Saratov, Russian Federation, 410040
      • Soshi, Russian Federation, 354057
      • St Petersburg, Russian Federation, 197022
      • St Petersburg, Russian Federation, 194044
      • St Petersburg, Russian Federation, 194291
      • St Petersburg, Russian Federation, 195067
      • St Petersburg, Russian Federation, 195275
      • St Petersburg, Russian Federation, 198103
      • St Petersburg, Russian Federation, 199034
      • St. Petersburg, Russian Federation, 191167
      • Stavropol, Russian Federation, 355017
      • Surgut, Russian Federation, 628400
      • Tjumen, Russian Federation, 629806
      • Tomsk, Russian Federation, 634050
      • Tumen, Russian Federation, 625002
      • Tumen, Russian Federation, 625017
      • Tumen, Russian Federation, 625026
      • UFA, Russian Federation, 450005
      • UFA, Russian Federation, 450000
      • Ulan-ude, Russian Federation, 670042
      • Vladivostok, Russian Federation, 690011
      • Vladivostok, Russian Federation, 690065
      • Volgograd, Russian Federation, 400138
      • Volgograd, Russian Federation, 400040
      • Yakutsk, Russian Federation, 677000
      • Yujno-sakhalinsk, Russian Federation, 690000
      • Yujno-sakhalinsk, Russian Federation, 693000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • serological evidence of chronic hepatitis C;
  • detectable serum HCV-RNA;
  • liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

  • history or other evidence of a medical condition associated with chronic liver disease other than HCV;
  • co-infection with active hepatitis A or B;
  • hepatocellular carcinoma;
  • patients with severe cardiovascular disease whose condition may worsen due to acute anemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: peginterferon alfa-2a [Pegasys]
180micrograms sc weekly for 12-48 weeks
Drug: ribavirin
800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)
Time Frame: From signing of informed consent up to end of study (up to Week 72)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.
From signing of informed consent up to end of study (up to Week 72)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy
Time Frame: 24 weeks after end of therapy (Week 72)
SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.
24 weeks after end of therapy (Week 72)
Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation
Time Frame: Weeks 12,24 and 48 After Therapy Initiation
HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48.
Weeks 12,24 and 48 After Therapy Initiation
Percentage of Participants With Change in Hemoglobin Level
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)
Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion.
Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

December 11, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML16709

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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