Back to resultsRollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Tenofovir DF
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- Complete all end of study visit procedures for the GS US 174-0108 study.
- Willing and able to provide written informed consent.
- A negative pregnancy test is required for female subjects at the end of study visit (i.e., screening visit for study GS-US-174-0141) for GS US 174-0108 (unless surgically sterile or greater than two years post-menopausal)
- All sexually active female subjects who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study.
- Male subjects who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.
Exclusion Criteria:
• Not Applicable
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tenofovir DF
Arm Description
Outcomes
Primary Outcome Measures
No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01334567
Brief Title
Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan
Official Title
A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to offer subjects from centers in Taiwan who successfully complete 168 weeks of treatment in study GS US 174-0108 access to treatment with tenofovir DF for up to three additional years (144 weeks). Subjects will be followed per local standard of care. Serious adverse events (SAEs), drug accountability and patient disposition will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tenofovir DF
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tenofovir DF
Other Intervention Name(s)
Viread®
Intervention Description
Provision of tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablets, as prescribed by study investigators
Primary Outcome Measure Information:
Title
No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
Complete all end of study visit procedures for the GS US 174-0108 study.
Willing and able to provide written informed consent.
A negative pregnancy test is required for female subjects at the end of study visit (i.e., screening visit for study GS-US-174-0141) for GS US 174-0108 (unless surgically sterile or greater than two years post-menopausal)
All sexually active female subjects who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study.
Male subjects who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.
Exclusion Criteria:
• Not Applicable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Flaherty, PharmD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Kaoshiung Hsien
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan Hsien
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan
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