Hepatitis BPhase 2NCT00644761
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
A Phase 2 study testing Adefovir Dipivoxil in people with Hepatitis B, run by Gilead Sciences at 11 sites in United States.
Trial summary
Open-label pharmacokinetic drug interaction study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Adefovir Dipivoxil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2004to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Baylor Research Institute
Dallas, Texas, 75204
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Miami
Miami, Florida, 33136
NYU Medical Center
New York, New York, 10016
Columbia Presbyterian Medical Center
New York, New York, 10032
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, New York, 55905
California Pacific Medical Center
San Francisco, California, 94115
University of California, San Francisco
San Francisco, California, 94143
About this study
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
Open-label pharmacokinetic drug interaction study.
Read the 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.
- Conditions
- Hepatitis B
- Being tested
- Adefovir Dipivoxil
- Keywords
- Hepatitis B, Post-Liver Transplantation, Adefovir Dipivoxil, Tacrolimus, Cyclosporine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adefovir DipivoxilDrug
Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Other | Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days Receives: Drug: Adefovir Dipivoxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation
Measured: 21 days
Secondary outcomes (1)
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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startFeb 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644761
- Sponsor's protocol ID
- GS-02-531
- Status last verified
- Apr 2008
- First submitted
- 21 Mar 2008
- Last updated
- 10 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00644761
- Acronym / sponsor ID
- GS-02-531
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Post-Liver Transplantation, Adefovir Dipivoxil, Tacrolimus, Cyclosporine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label pharmacokinetic drug interaction study.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Other | Drug: Adefovir DipivoxilAdefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adefovir DipivoxilAdefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine | Drug | Treatment Arm 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2008.
- Study ResultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adefovir Dipivoxil in people with Hepatitis B, run by Gilead Sciences at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2008.