Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B

NCT00071201 | Completed Phase 3

• 1 other identifier: GS-02-526
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and varying degrees of renal impairment.

Conditions

Chronic Hepatitis B

Interventions

Adefovir Dipivoxil for oral suspension, 2 mg/mL DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ages 18 through 65 years
• Able to give written informed consent and comply with the requirements of the study
• Females of childbearing potential must have a negative serum pregnancy test at screening and must use effective methods of contraception throughout the study.
• Positive serum HBV DNA equal to or greater than 100,000 copies/mL
• Patients with abnormal renal function, defined as a calculated creatinine clearance less than 80 mL/min, or end stage renal disease undergoing hemodialysis
• For non-hemodialysis patients, renal function must be "stable"
• ALT value equal to or greater than 1.2 to equal to or less than 15 times the upper limit of normal on at least two occasions, or histological evidence of necroinflammation and/or fibrosis
• Compensated liver disease with the following:
• Prothrombin time equal to or less than to 1 second above normal range
• Total bilirubin equal to or less than to 2.5 mg/dL or normal direct bilirubin
• No history of variceal bleeding or encephalopathy
• HIV, HCV, and HDV seronegative
• Adequate hematological function defined as:
• Absolute neutrophil count equal to or greater than 750/mm3
• Platelets equal to or greater than 50,000/mm3

You may not qualify if:

• Inability to comply with study requirements
• Lactating or pregnant females
• History or current manifestations of clinically significant cardiac, respiratory, endocrine (including diabetes mellitus), metabolic, gastrointestinal, dermatological, infectious, malignant, hematological, neurological, rheumatologic or psychiatric disorder, which is not related to the patient's renal insufficiency or deemed by the investigator to preclude suitability for pharmacokinetic assessment or interfere with patient treatment, assessment, or compliance with the protocol
• Received interferon within 6 months prior to study screening
• Bone marrow transplant recipients
• Renal transplant less than 6 months prior to study entry, or clinical evidence of rejection
• Patients expected to receive organ transplantation within 48 weeks
• Evidence of active liver disease due to other causes
• Patients taking chemotherapeutic agents within 2 months or expected to receive these agents during the study
• Previous participation in an investigational trial involving any investigational compound within 2 months, or within 5 half-lives of the study drug if sooner
• History of alcohol or drug abuse sufficient to hinder compliance with protocol
• Child-Pugh-Turcotte score over 9
• Evidence of hepatic mass suggestive of hepatocellular carcinoma
• History of malignancy other than basal cell carcinoma or treated cervical carcinoma in situ or cervical dysplasia
• The use of systemic drugs with potential activity against HBV for a period of more than 12 weeks in duration at any time

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences, Inc. 333 Lakeside Drive

Foster City, California, 94404, United States

Location

Related Publications (3)

• Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang TT, Kitis G, Rizzetto M, Marcellin P, Lim SG, Goodman Z, Wulfsohn MS, Xiong S, Fry J, Brosgart CL; Adefovir Dipivoxil 438 Study Group. Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl J Med. 2003 Feb 27;348(9):800-7. doi: 10.1056/NEJMoa021812.

  PMID: 12606734 BACKGROUND

• Marcellin P, Chang TT, Lim SG, Tong MJ, Sievert W, Shiffman ML, Jeffers L, Goodman Z, Wulfsohn MS, Xiong S, Fry J, Brosgart CL; Adefovir Dipivoxil 437 Study Group. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med. 2003 Feb 27;348(9):808-16. doi: 10.1056/NEJMoa020681.

  PMID: 12606735 BACKGROUND

• Westland CE, Yang H, Delaney WE 4th, Gibbs CS, Miller MD, Wulfsohn M, Fry J, Brosgart CL, Xiong S; 437 and 438 Study Teams. Week 48 resistance surveillance in two phase 3 clinical studies of adefovir dipivoxil for chronic hepatitis B. Hepatology. 2003 Jul;38(1):96-103. doi: 10.1053/jhep.2003.50288.

  PMID: 12829991 BACKGROUND

Related Links

• Gilead's website
• Study Results

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

adefovir dipivoxil; Suspensions

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2003
• First Posted: October 17, 2003
• Study Start: June 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)