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

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 Interferons Peginterferon Alfa-2b

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

Investigators


Principal Investigator:	Daozhen Xu, M.D.	Beijing Di Tan Hospital, China

Principal Investigator:	Jun Cheng	Beijing Di Tan Hospital, China

More Information

Responsible Party:	Schering-Plough ( Jasmine Sun, MD - Medical Director, China Country Operations )
Study ID Numbers:	P05170
First Received:	September 26, 2007
Last Updated:	October 21, 2008
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

Peginterferon alfa-2b

Hepatitis B

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 October 24, 2008

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