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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6661

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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