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PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00644761
First received: March 21, 2008
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

Open-label pharmacokinetic drug interaction study.


Condition Intervention Phase
Hepatitis B
Drug: Adefovir Dipivoxil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Phase 2, Open-Label Study to Evaluate the Pharmacokinetics of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil 10 mg to Patients Post-Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate PK of ADV 10 mg once daily when co-administered with tacrolimus or cyclosporine in patients post-liver transplantation. To evaluate the safety of ADV 10 mg once daily, when co-administered with tacrolimus or cyclosporine for 14 days. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment Arm 1
Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days
Drug: Adefovir Dipivoxil
Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine

Detailed Description:

Multi-center, phase 2, open-label, sequential-cohort, drug interaction study. Cohort 1 subjects (tacrolimus and adefovir dipivoxil) were enrolled first. Based on the findings in Cohort 1, a decision was made on whether to enroll subjects in Cohort 2 (cyclosporine and adefovir dipivoxil)(i.e., if no interaction was observed in Cohort 1, Cohort 2 subjects would not be enrolled). Since no pharmacokinetic interaction was observed in Cohort 1, Cohort 2 was not enrolled.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 years of age
  • Greater than or equal to 6 months post-liver transplantation
  • Must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months.
  • Must have calculated creatinine clearance greater than or equal 50 mL/min (Cockcroft-Gault method).
  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: NCT00644761

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
California Pacific Medical Center
San Francisco, California, United States, 94115
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
NYU Medical Center
New York, New York, United States, 10016
Mayo Clinic
Rochester, New York, United States, 55905
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Elsa Mondou, MD, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00644761     History of Changes
Other Study ID Numbers: GS-02-531
Study First Received: March 21, 2008
Last Updated: April 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis B
Post-Liver Transplantation
Adefovir Dipivoxil
Tacrolimus
Cyclosporine

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases
Adefovir
Adefovir dipivoxil
Cyclosporine
Cyclosporins
Tacrolimus
Anti-Infective Agents
Anti-Retroviral Agents
Antifungal Agents
Antirheumatic Agents
Antiviral Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014