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Evaluation of Chronic HBV Patients w/Evidence of HBV Replication and Normal or Minimally Elevated Liver Transaminases.

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00263614
First received: December 8, 2005
Last updated: January 30, 2009
Last verified: January 2009
  Purpose

To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated liver transaminases have histological evidence of active liver disease.


Condition Phase
Chronic Hepatitis B
Phase 4

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Cross Sectional and Retrospective Evaluation in HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)Patients With Evidence of HBV Replication and Normal or Minimally Elevated Liver Transaminases(The MELT Study).

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Estimated Enrollment: 100
Study Start Date: December 2005
Study Completion Date: June 2007
Detailed Description:

To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated liver transaminases have histological evidence of active liver disease.

  Eligibility

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

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be included in this study:

Age greater than or equal to 18 years. Documented laboratory diagnosis of HBV infection (HBsAg positive) at least 6 months prior to inclusion in this study. Treatment naive, HBeAg-positive and HBeAg-negative patients. At least one liver biopsy specimen obtained in 2004 and/or 2005 (post diagnosis) that is available for evaluation by an independent pathologist. Gilead may allow enrollment of subjects with biopsies available from 2003. An adequate section of a biopsy for the purposes of this study should have at least 1 cm of the needle core of tissue on the slide. HBV DNA greater than or less than 5 log10 copies/mL for HBeAg-positive and greater than or less than 4 log10 copies/mL for HBeAg negative patients. A minimum of two normal or minimally elevated hepatic transminases (ALT) values that are at least 3 months apart during 2004 and/or 2005. Gilead may allow enrollment of subjects with values available from 2003. Minimally elevated ALT is defined as between lower limit of normal (LLN) and 1.2 times upper limit of normal (ULN) for HBeAg-positive and between lower limit of normal (LLN) and 1.5 times upper limit of normal (ULN) for HBeAg-negative patients. Child-Turcotte-Pugh score less than 7 and no evidence of ascites, variceal bleeding, or hepatic encephalopathy or impaired clotting function within 12 months prior to the Enrollment Visit.

Exclusion Criteria:Patients who meet any of the following criteria are excluded from the study:

History or evidence of HIV, hepatitic C, or hepatitis D. Other causes for liver disease other than hepatitis B, including but not limited to: hemochromatosis, Alpha-1 antitrypsin deficiency, Wilson's disease, Drug-related liver disease, Autoimmune hepatitis, Alcoholic liver disease, Obesity-induced liver disease (nonalcoholic seatohepatitis, NASH). History of, or current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory or biopsy results.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263614

Locations
United States, California
Gilead Sciences, Inc.
Foster City, California, United States, 94404
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: John Flaherty, PharmD Gilead Sciences
  More Information

Additional Information:
No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00263614     History of Changes
Other Study ID Numbers: GS-US-103-0143
Study First Received: December 8, 2005
Last Updated: January 30, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014