Lamivudine and Adefovir to Treat Chronic Hepatitis B

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Marc Ghany, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

ClinicalTrials.gov Identifier:

NCT00023309

First received: September 3, 2001

Last updated: February 21, 2013

Last verified: February 2013

History of Changes

Results First Received: July 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	HBV (Hepatitis B Virus) Hepatitis B Hepatitis
Interventions:	Drug: Lamivudine and adefovir Drug: Adefovir alone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Forty-one patients were enrolled, twenty-two were randomized to receive the combination lamivudine and adefovir and nineteen to receive adefovir alone.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Lamivudine and Adefovir	Patients to receive combination lamivudine and adefovir, with lamivudine of 100 mg daily and adefovir of 10 mg daily
Adefovir	Patients to receive adefovir alone (10 mg daily).

Participant Flow: Overall Study

	Lamivudine and Adefovir	Adefovir
STARTED	22	19
COMPLETED	22	19
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Lamivudine and Adefovir	Patients to receive combination lamivudine and adefovir
Adefovir	Patients to receive adefovir alone
Total	Total of all reporting groups

Baseline Measures

	Lamivudine and Adefovir	Adefovir	Total
Number of Participants [units: participants]	22	19	41
Age [units: years] Mean ± Standard Deviation	46 ± 14	45 ± 13	45 ± 14
Gender [units: participants]
Female	6	1	7
Male	16	18	34
Race/Ethnicity, Customized [units: participants]
White	9	8	17
Asian	9	10	19
Black	4	1	5
Region of Enrollment [units: participants]
United States	22	19	41
Treatment Naive [units: participants]
Yes	17	14	31
No	5	5	10
HBeAg positive [units: participants]
Yes	17	14	31
No	5	5	10
ALT ^[1] [units: IU/ml] Mean ± Standard Deviation	183 ± 250	87 ± 56	139 ± 187
HBV DNA Log 10 copies per ml ^[2] [units: log10(copies/ml)] Mean ± Standard Deviation	8.1 ± 1.3	7.8 ± 1.6	8.0 ± 1.4
HAI ^[3] [units: Units on a scale] Mean ± Standard Deviation	8.1 ± 2.7	7.9 ± 2.4	8.0 ± 2.6
Ishak ^[4] [units: Units on a scale] Mean ± Standard Deviation	3.3 ± 1.7	2.4 ± 1.5	2.9 ± 1.6
Cirrhosis [units: participants]
Yes	5	2	7
No	17	17	34

[1]	Alanine transaminase
[2]	Hepatitis B virus DNA logarithm 10 copies per ml
[3]	HAI Fibrosis score for liver histology, which has a range 0–18 and higher values represent a worse outcome
[4]	Ishak Fibrosis Score, (range 0–6, where 0 = no fibrosis and 6 = cirrhosis)

Outcome Measures

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1. Primary:

Maintained Combined Response (Virological, Biochemical and Histological Response). [ Time Frame: 196 weeks from randomization ]

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2. Secondary:

HBeAg Loss at Week 196 [ Time Frame: Week 196 from randomization ]

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3. Secondary:

Virological Response [ Time Frame: Week 196 from randomization ]

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4. Secondary:

Biological Response [ Time Frame: week 196 from randomization ]

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5. Secondary:

Histological Response [ Time Frame: week 196 from randomization ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Marc G. Ghany, M.D
Organization: National Institute of Diabetes and Digestive and Kidney Diseases, NIH
phone: 3014961721
e-mail: marcg@mail.nih.gov

Publications:

Niederau C, Heintges T, Lange S, Goldmann G, Niederau CM, Mohr L, Haussinger D. Long-term follow-up of HBeAg-positive patients treated with interferon alfa for chronic hepatitis B. N Engl J Med. 1996 May 30;334(22):1422-7.

Malik AH, Lee WM. Chronic hepatitis B virus infection: treatment strategies for the next millennium. Ann Intern Med. 2000 May 2;132(9):723-31. Review.

Hoofnagle JH, di Bisceglie AM. The treatment of chronic viral hepatitis. N Engl J Med. 1997 Jan 30;336(5):347-56. Review. No abstract available.

Responsible Party:	Marc Ghany, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00023309 History of Changes
Other Study ID Numbers:	010246, 01-DK-0246
Study First Received:	September 3, 2001
Results First Received:	July 7, 2011
Last Updated:	February 21, 2013
Health Authority:	United States: Federal Government United States: Food and Drug Administration

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