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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00922779
First received: June 16, 2009
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Adverse events; laboratory parameters [ Time Frame: Throughout study; recorded at each clinic visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained viral response [ Time Frame: 24 weeks after end of therapy ] [ Designated as safety issue: No ]

Enrollment: 7754
Study Start Date: June 2002
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922779

  Hide Study Locations
Locations
Russian Federation
Arkhangelsk, Russian Federation, 163000
Barnaul, Russian Federation, 656010
Barnaul, Russian Federation, 656045
Blagoveshchensk, Russian Federation, 675007
Cheboksary, Russian Federation, 428016
Chelyabinsk, Russian Federation, 454052
Chelyabinsk, Russian Federation, 454071
Chelyabinsk, Russian Federation, 454048
Cherepovets, Russian Federation, 162600
Chita, Russian Federation, 672090
Ekaterinburg, Russian Federation, 620042
Ekaterinburg, Russian Federation, 620102
Ekaterinburg, Russian Federation, 620020
Irkutsk, Russian Federation, 664043
Irkutsk, Russian Federation, 664047
Irkutsk, Russian Federation, 664079
Izhevsk, Russian Federation, 426067
Kazan, Russian Federation, 420097
Kemerovo, Russian Federation, 650000
Kemerovo, Russian Federation, 650036
Kemerovo, Russian Federation, 650099
Khabarovsk, Russian Federation, 680022
Khabarovsk, Russian Federation, 680031
Khabarovsk, Russian Federation, 680009
Kirov, Russian Federation, 610000
Krasnodar, Russian Federation, 350086
Krasnodar, Russian Federation, 350015
Krasnodar, Russian Federation, 350012
Krasnoyarsk, Russian Federation, 660022
Krasnoyarsk, Russian Federation, 660049
Lipetsk, Russian Federation, 398043
Makhachkala, Russian Federation, 367008
Moscow, Russian Federation
Moscow, Russian Federation, 115682
Moscow, Russian Federation, 111123
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 143420
Moscow, Russian Federation, 103875
Moscow, Russian Federation, 123098
Moscow, Russian Federation, 115516
Moscow, Russian Federation, 115446
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 115201
Moscow, Russian Federation, 119881
Moscow, Russian Federation, 121293
Moscow, Russian Federation, 123367
Moscow, Russian Federation, 119002
Moscow, Russian Federation, 109325
Moscow, Russian Federation, 105203
Moscow, Russian Federation, 125367
Moscow, Russian Federation, 127247
Moscow, Russian Federation, 111020
Nizhny Novgorod, Russian Federation, 603022
Novokuznetsk, Russian Federation, 654029
Novokuznetsk, Russian Federation, 654018
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, 443021
Samara, Russian Federation, 443011
Saratov, Russian Federation, 410028
Saratov, Russian Federation, 410026
Saratov, Russian Federation, 410040
Soshi, Russian Federation, 354057
St Petersburg, Russian Federation, 194044
St Petersburg, Russian Federation, 199034
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation, 198103
St Petersburg, Russian Federation, 194291
St Petersburg, Russian Federation, 195275
St Petersburg, Russian Federation, 195067
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, 625026
Tumen, Russian Federation, 625017
UFA, Russian Federation, 450005
UFA, Russian Federation, 450000
Ulan-ude, Russian Federation, 670042
Vladivostok, Russian Federation, 690065
Vladivostok, Russian Federation, 690011
Volgograd, Russian Federation, 400138
Volgograd, Russian Federation, 400040
Yakutsk, Russian Federation, 677000
Yujno-sakhalinsk, Russian Federation, 690000
Yujno-sakhalinsk, Russian Federation, 693000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00922779     History of Changes
Other Study ID Numbers: ML16709
Study First Received: June 16, 2009
Last Updated: August 4, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014