A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00614471

Purpose

This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals.

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

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Entecavir Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment
Official Title:	A Randomized, Open Label Study of the Effect of Peginterferon Alfa-2a (40KD) (PEGASYS®) Plus Entecavir (Baraclude®) Combination Therapy on Quantitative Changes in HBeAg in Treatment-Naive Patients With HBeAg Positive Chronic Hepatitis B

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment. [ Time Frame: Week 72 for Arms 1 and 2. Week 92 for Arm 3. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment. [ Time Frame: Week 72 for Arms 1 and 2. Week 92 for Arm 3. ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2012

Arms	Assigned Interventions
1: Active Comparator	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc/week for 48 weeks
2: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc/week for 48 weeks Drug: Entecavir 0.5mg po daily from week 13 to week 36
3: Experimental	Drug: Entecavir 0.5mg po daily for 24 weeks Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc/week from week 21 to week 68

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-65 years of age;
HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
absence of cirrhosis confirmed by liver biopsy in previous 12 months.

Exclusion Criteria:

previous treatment for chronic hepatitis B within previous 6 months;
antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614471

Contacts

Contact: Please reference Study ID Number: ML20742	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

China
	Recruiting
SHANGHAI, China, 200025
	Terminated
HONG KONG, China
	Recruiting
HANGZHOU, China, 310003
	Recruiting
XI'AN, China, 710038
	Recruiting
SHANGHAI, China, 450052
	Recruiting
BEIJING, China, 100011
	Recruiting
ZHENGZHOU, China, 450052
	Recruiting
SHANGHAI, China, 200021

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:	ML20742
Study First Received:	January 30, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00614471 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents
Hepatitis

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

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions
Hepatitis

Virus Diseases
Digestive System Diseases
Entecavir
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
Peginterferon alfa-2a
DNA Virus Infections
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon Alfa-2a

ClinicalTrials.gov processed this record on March 16, 2009