PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (Study P05170) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00536263

Purpose

The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating e antigen-positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.

Condition	Intervention	Phase
Hepatitis B, Chronic	Drug: pegylated interferon alpha-2b	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment
Official Title:	An Open-Label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

HBeAg Loss [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HBe seroconversion [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]
HBV-DNA decrease [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]
ALT normalization [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]
Combined Response (defined as HBV DNA (PCR) <20,000 IUs/ml and HBe seroconversion and ALT normalization) [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]
HBsAg Loss [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]
HBs seroconversion [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	645
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Experimental PegIntron 1.0mcg/kg QW * 24 wks + 24 wks follow-up	Drug: pegylated interferon alpha-2b 1.0mcg/kg S.C. QW for 24 weeks
Arm B: Experimental PegIntron 1.5mcg/kg QW * 24 wks + 24 wks follow-up	Drug: pegylated interferon alpha-2b 1.5mcg/kg S.C. QW for 24 weeks
Arm C: Experimental PegIntron 1.5mcg/kg QW * 48 wks + 24 wks follow-up	Drug: pegylated interferon alpha-2b 1.5mcg/kg S.C. QW for 48 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults with chronic hepatitis B:
- Serum hepatitis B surface antigen positive for at least 6 months
- Serum hepatitis B e antigen positive
- Serum negative for hepatitis B surface and e antibodies
- Serum hepatitis B virus DNA level greater than 20,000 IU/mL
- ALT 2- to 10-times the upper limit of normal
Compensated liver disease with certain minimum hematological and serum biochemical criteria

Exclusion Criteria:

Significant hepatic disease from an etiology other than hepatitis B virus
Antiviral treatment for hepatitis within previous 6 months
History of severe psychiatric disease, especially depression
Unstable or significant cardiovascular disease
Prolonged exposure to known hepatotoxins such as alcohol or drugs
Any condition that could interfere with the subject participating in and completing the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536263

Locations

China
Investigational Site 12
Chongqing, China, 400038
Investigational Site 1
Beijing, China, 100011
Investigational Site 2
Beijing, China, 100054
Investigational Site 3
Beijing, China, 100039
Investigational Site 4
Beijing, China, 100034
Investigational Site 5
Beijing, China, 100044
Investigational Site 13
Chongqing, China, 400010
Investigational Site 7
Shanghai, China, 200025
Investigational Site 9
Guangzhou, China, 510515
Investigational Site 10
Guangzhou, China, 510630
Investigational Site 11
Chengdu, China, 610041
Investigational Site 6
Shanghai, China, 200040
Investigational Site 14
Chongqing, China, 400016
Investigational Site 15
Hangzhou, China, 310003
Investigational Site 16
Jinan, China, 250021
Investigational Site 17
Wuhan, China, 430030
Investigational Site 20
Fuzhou, China, 350025
Investigational Site 19
Shenzhen, China, 518020
Investigational Site 18
Wuhan, China, 430022
Investigational Site 21
Zhengzhou, China, 450003
Investigational Site 8
Shanghai, China, 200433
Malaysia
Investigational Site 24
Kuala Lumpur, Malaysia, 50603
Singapore
Investigational Site 26
Singapore, Singapore, 228510
Taiwan
Investigational Site 23
Taipei, Taiwan, 100
Investigational Site 25
Taipei, Taiwan, 220

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Jasmine Sun, MD - Medical Director, China Country Operations )
Study ID Numbers:	P05170
Study First Received:	September 26, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00536263
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

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

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

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
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 15, 2009