search
Back to results

A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Peginterferon alfa-2a
Ribavirin
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  • Adult participants at least 18 years of age
  • Chronic hepatitis C, with detectable serum hepatitis C virus (HCV) ribonucleic acid (RNA)
  • Scheduled for treatment with peginterferon alfa-2a
  • Compensated liver disease
  • Women in fertile age must be informed about obligation of using adequate contraception during and 6 months post treatment with ribavirin (Copegus®)
  • Men with a sexual partner in fertile age must be informed about obligatory contraception preventing pregnancy during the course of treatment with ribavirin (Copegus®) as well as 6 months after treatment cessation
  • Female participants in the study must have a negative pregnancy test performed not sooner than within 2 weeks preceding the planned inclusion to the study
  • Men with a sexual partner in fertile age must produce a negative result of the partner's pregnancy test performed not sooner than within 2 weeks preceding the planned partner's inclusion to the study

Exclusion Criteria:

  • Chronic liver disease other than chronic hepatitis C
  • Active hepatitis A virus or hepatitis B virus infection
  • Therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment less than or equal to (<=) 6 months prior to first dose of study drug
  • Hemoglobin <120 grams per liter (g/L) in female participants or <130 g/L in male participants (the result must not be older than 2 weeks prior to inclusion to the study)
  • Platelet count <90 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study
  • Neutrofil count <1.5 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study)
  • Participants with increased risk of anaemia, or participants at risk of serious health problems resulting from anaemia or decrease of hemoglobin (e.g., participants with serious cardiovascular or cerebrovascular disease)
  • History or presence of a serious mental disease, especially depression, which, in the investigator's opinion, does not allow administration of peginterferon alfa-2a (Pegasys®)
  • History or presence of a disease consequent to immunodeficiency (e.g., inflammatory diseases of intestine, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 1000-1200 mg PO daily (dependent on body weight) for 48 weeks.

Participants with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks.

Participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virological Response
Sustained virological response is defined as having no hepatitis C (HCV) virus detectable in the blood 24 weeks after end of treatment.

Secondary Outcome Measures

Percentage of Participants With End-of-Treatment Virological Response
End-of-treatment virological response is defined as having no HCV virus detectable in the blood immediately after end of treatment.
Percentage of Participants With Early-Treatment Virological Response
Early-treatment virological response is defined as having no HCV virus detectable in the blood or a 2-log (100-fold) decrease in HCV virus concentration in the blood after 12 weeks of study treatment.
Percentage of Participants With Adverse Events
An adverse event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsen during the study are reported as adverse events.

Full Information

First Posted
December 1, 2008
Last Updated
May 19, 2017
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00800748
Brief Title
A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C
Official Title
An Open, Phase IV, Multicentric Study, Evaluating Safety and Efficacy of Ribavirin (Copegus®) and Peginterferon Alfa-2a (Pegasys®) Combination in Specific Groups
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2006 (Actual)
Primary Completion Date
January 9, 2009 (Actual)
Study Completion Date
January 9, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants were studied; 1) those with elevated alanine transaminase (ALT) levels, 2) those with normal ALT levels, and 3) those with human immunodeficiency virus (HIV) co-infection. Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (PO) daily (dependent on body weight) for 48 weeks. Those with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks, and all participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 1000-1200 mg PO daily (dependent on body weight) for 48 weeks.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Participants with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks.
Arm Title
Group C
Arm Type
Experimental
Arm Description
Participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virological Response
Description
Sustained virological response is defined as having no hepatitis C (HCV) virus detectable in the blood 24 weeks after end of treatment.
Time Frame
Up to 72 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With End-of-Treatment Virological Response
Description
End-of-treatment virological response is defined as having no HCV virus detectable in the blood immediately after end of treatment.
Time Frame
Up to 48 weeks
Title
Percentage of Participants With Early-Treatment Virological Response
Description
Early-treatment virological response is defined as having no HCV virus detectable in the blood or a 2-log (100-fold) decrease in HCV virus concentration in the blood after 12 weeks of study treatment.
Time Frame
Up to 12 weeks
Title
Percentage of Participants With Adverse Events
Description
An adverse event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsen during the study are reported as adverse events.
Time Frame
Up to 72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult participants at least 18 years of age Chronic hepatitis C, with detectable serum hepatitis C virus (HCV) ribonucleic acid (RNA) Scheduled for treatment with peginterferon alfa-2a Compensated liver disease Women in fertile age must be informed about obligation of using adequate contraception during and 6 months post treatment with ribavirin (Copegus®) Men with a sexual partner in fertile age must be informed about obligatory contraception preventing pregnancy during the course of treatment with ribavirin (Copegus®) as well as 6 months after treatment cessation Female participants in the study must have a negative pregnancy test performed not sooner than within 2 weeks preceding the planned inclusion to the study Men with a sexual partner in fertile age must produce a negative result of the partner's pregnancy test performed not sooner than within 2 weeks preceding the planned partner's inclusion to the study Exclusion Criteria: Chronic liver disease other than chronic hepatitis C Active hepatitis A virus or hepatitis B virus infection Therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment less than or equal to (<=) 6 months prior to first dose of study drug Hemoglobin <120 grams per liter (g/L) in female participants or <130 g/L in male participants (the result must not be older than 2 weeks prior to inclusion to the study) Platelet count <90 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study Neutrofil count <1.5 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study) Participants with increased risk of anaemia, or participants at risk of serious health problems resulting from anaemia or decrease of hemoglobin (e.g., participants with serious cardiovascular or cerebrovascular disease) History or presence of a serious mental disease, especially depression, which, in the investigator's opinion, does not allow administration of peginterferon alfa-2a (Pegasys®) History or presence of a disease consequent to immunodeficiency (e.g., inflammatory diseases of intestine, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Beroun
Country
Czechia
City
Brno
ZIP/Postal Code
62500
Country
Czechia
City
Ceska Lipa
Country
Czechia
City
Ceské Budejovice
ZIP/Postal Code
370 87
Country
Czechia
City
Chomutov
Country
Czechia
City
Decin
ZIP/Postal Code
0
Country
Czechia
City
Havirov
Country
Czechia
City
Havlickuv Brod
Country
Czechia
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
City
Hradec Kralove
Country
Czechia
City
Jablonec/nisou
ZIP/Postal Code
466 60
Country
Czechia
City
Jihlava
Country
Czechia
City
Karlovy Vary
Country
Czechia
City
Kolin
Country
Czechia
City
Liberec
Country
Czechia
City
Melnik
Country
Czechia
City
Most
Country
Czechia
City
Olomouc
Country
Czechia
City
Opava
Country
Czechia
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
City
Pardubice
Country
Czechia
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
City
Praha
ZIP/Postal Code
00000
Country
Czechia
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
City
Praha
ZIP/Postal Code
180 01
Country
Czechia
City
Praha
Country
Czechia
City
Prostejov
Country
Czechia
City
Usti Nad Labem
Country
Czechia
City
Banska Bystrica
ZIP/Postal Code
957 17
Country
Slovakia
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
City
Trencin
ZIP/Postal Code
911 07
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C

We'll reach out to this number within 24 hrs