Hepatitis BPhase 2NCT01334567
Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan
A Phase 2 study testing Tenofovir DF in people with Hepatitis B, run by Gilead Sciences at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Tenofovir DF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesTaiwan
- Study dates
- Aug 2010to Dec 2013
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not Applicable
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Study site
Kaoshiung Hsien
Study site
Tainan
Study site
Taipei
Study site
Taoyuan Hsien
About this study
Official title: A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108
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.
- Conditions
- Hepatitis B
- Being tested
- Tenofovir DF
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir DFDrug
Also called Viread®
Provision of tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablets, as prescribed by study investigators
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir DF | Experimental | Not described Receives: Drug: Tenofovir DF |
What is being measured
The primary outcome is the main question the study is designed to answer.
No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2013
- Study completionDec 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Flaherty, PharmD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334567
- Sponsor's protocol ID
- GS-US-174-0141
- Status last verified
- Feb 2014
- First submitted
- 4 Nov 2010
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108
- ClinicalTrials.gov ID
- NCT01334567
- Acronym / sponsor ID
- GS-US-174-0141
- Conditions
- Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Apr 2011 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenofovir DF | Experimental | Drug: Tenofovir DF |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Not Applicable
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 |
|---|---|---|
| Tenofovir DFAlso: Viread®Provision of tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablets, as prescribed by study investigators | Drug | Tenofovir DF |
Primary outcome
No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs.
Time frame: 3 years
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 4 Mar 2014.
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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.
John Flaherty, PharmD study director
Gilead Sciences
4 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 Tenofovir DF in people with Hepatitis B, run by Gilead Sciences at 4 sites in Taiwan.
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 6 inclusion and 1 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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs. (time frame: 3 years). 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 4 Mar 2014.