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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)
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.

Secondary Outcome Measures

Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy
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.
Percentage of Participants With Undetectable HCV RNA at 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.
Percentage of Participants With Change in Hemoglobin Level
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.

Full Information

First Posted
June 16, 2009
Last Updated
December 11, 2015
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00922779
Brief Title
A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
Official Title
Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
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.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6661 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180micrograms sc weekly for 12-48 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)
Primary Outcome Measure Information:
Title
Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)
Description
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.
Time Frame
From signing of informed consent up to end of study (up to Week 72)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy
Description
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.
Time Frame
24 weeks after end of therapy (Week 72)
Title
Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation
Description
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.
Time Frame
Weeks 12,24 and 48 After Therapy Initiation
Title
Percentage of Participants With Change in Hemoglobin Level
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
City
Barnaul
ZIP/Postal Code
656010
Country
Russian Federation
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
City
Blagoveshchensk
ZIP/Postal Code
675007
Country
Russian Federation
City
Cheboksary
ZIP/Postal Code
428016
Country
Russian Federation
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
City
Chelyabinsk
ZIP/Postal Code
454052
Country
Russian Federation
City
Chelyabinsk
ZIP/Postal Code
454071
Country
Russian Federation
City
Cherepovets
ZIP/Postal Code
162600
Country
Russian Federation
City
Chita
ZIP/Postal Code
672090
Country
Russian Federation
City
Ekaterinburg
ZIP/Postal Code
620020
Country
Russian Federation
City
Ekaterinburg
ZIP/Postal Code
620042
Country
Russian Federation
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
City
Irkutsk
ZIP/Postal Code
664043
Country
Russian Federation
City
Irkutsk
ZIP/Postal Code
664047
Country
Russian Federation
City
Irkutsk
ZIP/Postal Code
664079
Country
Russian Federation
City
Izhevsk
ZIP/Postal Code
426067
Country
Russian Federation
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
City
Kemerovo
ZIP/Postal Code
650036
Country
Russian Federation
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
City
Khabarovsk
ZIP/Postal Code
680009
Country
Russian Federation
City
Khabarovsk
ZIP/Postal Code
680022
Country
Russian Federation
City
Khabarovsk
ZIP/Postal Code
680031
Country
Russian Federation
City
Kirov
ZIP/Postal Code
610000
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350012
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350015
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
City
Krasnoyarsk
ZIP/Postal Code
660049
Country
Russian Federation
City
Lipetsk
ZIP/Postal Code
398043
Country
Russian Federation
City
Makhachkala
ZIP/Postal Code
367008
Country
Russian Federation
City
Moscow
ZIP/Postal Code
103875
Country
Russian Federation
City
Moscow
ZIP/Postal Code
105203
Country
Russian Federation
City
Moscow
ZIP/Postal Code
109325
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111020
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115201
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119002
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119881
Country
Russian Federation
City
Moscow
ZIP/Postal Code
121293
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123098
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123367
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127247
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
Moscow
ZIP/Postal Code
143420
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603022
Country
Russian Federation
City
Novokuznetsk
ZIP/Postal Code
654018
Country
Russian Federation
City
Novokuznetsk
ZIP/Postal Code
654029
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630016
Country
Russian Federation
City
Novouralsk
ZIP/Postal Code
624130
Country
Russian Federation
City
Omsk
ZIP/Postal Code
644010
Country
Russian Federation
City
Orenburg
ZIP/Postal Code
460035
Country
Russian Federation
City
Petropavlovsk-Kamchatskiy
ZIP/Postal Code
683003
Country
Russian Federation
City
Rostov-na-donu
ZIP/Postal Code
344022
Country
Russian Federation
City
Salekhard
ZIP/Postal Code
629001
Country
Russian Federation
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
City
Samara
ZIP/Postal Code
443021
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410026
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410040
Country
Russian Federation
City
Soshi
ZIP/Postal Code
354057
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
195275
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
198103
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
191167
Country
Russian Federation
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
City
Surgut
ZIP/Postal Code
628400
Country
Russian Federation
City
Tjumen
ZIP/Postal Code
629806
Country
Russian Federation
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
City
Tumen
ZIP/Postal Code
625002
Country
Russian Federation
City
Tumen
ZIP/Postal Code
625017
Country
Russian Federation
City
Tumen
ZIP/Postal Code
625026
Country
Russian Federation
City
UFA
ZIP/Postal Code
450000
Country
Russian Federation
City
UFA
ZIP/Postal Code
450005
Country
Russian Federation
City
Ulan-ude
ZIP/Postal Code
670042
Country
Russian Federation
City
Vladivostok
ZIP/Postal Code
690011
Country
Russian Federation
City
Vladivostok
ZIP/Postal Code
690065
Country
Russian Federation
City
Volgograd
ZIP/Postal Code
400040
Country
Russian Federation
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
City
Yakutsk
ZIP/Postal Code
677000
Country
Russian Federation
City
Yujno-sakhalinsk
ZIP/Postal Code
690000
Country
Russian Federation
City
Yujno-sakhalinsk
ZIP/Postal Code
693000
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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