A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00474955
First received: May 16, 2007
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hem odialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; tho se with a calculated glomerular filtration rate of <15mL/min will receive a redu ced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study tre atment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
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: An Open Label Study of the Effect of PEGASYS on Sustained Virological Response in Patients With Chronic Hepatitis C and Chronic Renal Failure

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with SVR [ Time Frame: 24 weeks after treatment completion ] [ Designated as safety issue: No ]
  • Percentage of patients with undetectable HCV-RNA [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with a 2log10 drop in HCV-RNA [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SAEs, premature withdrawals, AEs and laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: July 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-60 years of age;
  • chronic hepatitis C;
  • chronic renal failure, including patients on hemodialysis therapy;
  • detectable HCV RNA levels (>500IU/mL).

Exclusion Criteria:

  • concurrent active hepatitis A or B;
  • history or evidence of a medical condition associated with chronic liver disease other than HCV;
  • history or other evidence of decompensated liver disease;
  • therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months prior to study;
  • acute renal failure.
  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: NCT00474955

Locations
Russian Federation
Chelyabinsk, Russian Federation, 454071
Chita, Russian Federation, 672090
Ekaterinburg, Russian Federation, 620102
Irkutsk, Russian Federation, 664047
Khabarovsk, Russian Federation, 680022
Khabarovsk, Russian Federation, 680009
Moscow, Russian Federation, 123182
Orenburg, Russian Federation, 460040
St Petersburg, Russian Federation, 195067
St. Petersburg, Russian Federation, 191167
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: NCT00474955     History of Changes
Other Study ID Numbers: ML20434
Study First Received: May 16, 2007
Last Updated: July 7, 2014
Health Authority: Russia: Federal Agency of drug quality control

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Kidney Failure, Chronic
Renal Insufficiency
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014