A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00487747

Purpose

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks 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 B, Chronic	Drug: peginterferon alfa-2a (40KD) [PEGASYS]	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Peginterferon Alfa-2a Hepatitis B Vaccines

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 Treatment Response in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

HBV DNA <100,000 copies/mL (HBeAg positive patients) [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
HBV DNA <20,000 copies/mL (HBeAg negative patients) [ Time Frame: Week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HBV DNA <400 copies/mL, HbsAg seroconversion, ALT normalization, sustained HBe seroconversion in HBeAg positive patients. [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	August 2006
Estimated Study Completion Date:	February 2011

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 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-70 years of age;
chronic hepatitis B;
HBV DNA >100,000 copies/mL.

Exclusion Criteria:

previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
evidence of decompensated liver disease;
history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
coinfection with hepatitis A, C or D, or HIV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487747

Contacts

Contact: Please reference Study ID Number: ML20003	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Russian Federation
	Completed
MOSCOW, Russian Federation, 115516
	Recruiting
MOSCOW, Russian Federation, 119881
	Recruiting
MOSCOW, Russian Federation, 123367
	Recruiting
MOSCOW, Russian Federation, 111020
	Recruiting
MOSCOW, Russian Federation
	Terminated
KAZAN, Russian Federation, 420097
	Terminated
SAMARA, Russian Federation, 443021
	Recruiting
STAVROPOL, Russian Federation, 355017
	Completed
KRASNOYARSK, Russian Federation, 660049
	Completed
TOMSK, Russian Federation, 634050
	Recruiting
EKATERINBURG, Russian Federation, 620102
	Completed
EKATERINBURG, Russian Federation, 620102
	Terminated
NIZHNY NOVGOROD, Russian Federation, 603022
	Recruiting
ST PETERSBURG, Russian Federation, 190103
	Recruiting
ROSTOV-NA-DONU, Russian Federation, 344010
	Recruiting
TUMEN, Russian Federation, 625002
	Completed
IRKUTSK, Russian Federation, 664047
	Active, not recruiting
MOSCOW, Russian Federation, 121293
	Completed
UFA, Russian Federation, 450000
	Recruiting
VOLGOGRAD, Russian Federation, 400138
	Completed
YAKUTSK, Russian Federation, 677000
	Recruiting
EKATERINBURG, Russian Federation, 620020
	Completed
CHELYABINSK, Russian Federation, 454052
	Completed
NOVOKUZNETSK, Russian Federation, 654063
	Completed
NOVOSIBIRSK, Russian Federation, 630016

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20003
Study First Received:	June 18, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00487747
Health Authority:	Russia: Federal Agency of drug quality control

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Hepatitis
Virus Diseases

Digestive System Diseases
Hepatitis B, Chronic
Hepatitis B
Peginterferon alfa-2a
DNA Virus Infections
Interferon Alfa-2a

Additional relevant MeSH terms:

Anti-Infective Agents
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors

Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009