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

This study is currently recruiting participants.

Verified by Hoffmann-La Roche, April 2009

First Received: May 16, 2007 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00474955

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 hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of <15mL/min will receive a reduced 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 treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: peginterferon alfa-2a (40KD) [PEGASYS]	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis C Kidney Failure

Drug Information available for: Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	150
Study Start Date:	July 2007
Estimated Study Completion Date:	September 2012

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474955

Contacts

Contact: Please reference Study ID Number: ML20434	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Russian Federation
	Recruiting
MOSCOW, Russian Federation, 123182
	Recruiting
KHABAROVSK, Russian Federation, 680009
	Completed
EKATERINBURG, Russian Federation, 620102
	Recruiting
IRKUTSK, Russian Federation, 664047
	Recruiting
KHABAROVSK, Russian Federation, 680022
	Recruiting
ST PETERSBURG, Russian Federation, 191167
	Active, not recruiting
ST PETERSBURG, Russian Federation, 195067
	Recruiting
CHITA, Russian Federation, 672090
	Not yet recruiting
KRASNODAR, Russian Federation, 350086
	Completed
CHELYABINSK, Russian Federation, 454071

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20434
Study First Received:	May 16, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00474955 History of Changes
Health Authority:	Russia: Federal Agency of drug quality control

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Renal Insufficiency
Hepatitis, Chronic
Interferons
Kidney Failure, Chronic
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents
Hepatitis

Virus Diseases
Digestive System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Peginterferon alfa-2a
Hepatitis C
Kidney Diseases
Interferon Alfa-2a
Hepatitis C, Chronic
Kidney Failure

Additional relevant MeSH terms:

Anti-Infective Agents
Renal Insufficiency
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Antineoplastic Agents
Physiological Effects of Drugs
Kidney Failure, Chronic
Hepatitis, Viral, Human
Urologic Diseases
Therapeutic Uses
Growth Inhibitors
Hepatitis C
Kidney Diseases

Angiogenesis Modulating Agents
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Renal Insufficiency, Chronic
Peginterferon alfa-2a
Interferon Alfa-2a
Hepatitis C, Chronic
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009