Hepatitis CNCT02315638
Long-Term Follow-Up Safety Monitoring of Patients Dosed in the First-in-Man Phase I/II Study of TT-034.
An observational study of Hepatitis C, run by Tacere Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 24 Sep 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is comprised of subjects that were enrolled in Study B2801001 and who received a dose of TT-034.
Who may be able to join
- Prior enrollment in Study B2801001 and dosing with TT-034
- An informed consent form for this study signed and dated by the subject or a legally acceptable representative
Who cannot join
- There are no specific exclusion criteria for this follow-up study
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27710
About this study
Official title: Follow-up to Study Protocol B2801001, A Phase I/II, Open-Label Dose Escalation Study to Evaluate the Safety and Efficacy of Single Doses of TT-034 in Patients With Chronic Hepatitis C [CHC] Infection
This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years.
Read the detailed description
The main purpose of this follow-up study is to detect events suggestive of delayed adverse effects of the study drug by review of clinical histories and discussion with subjects to identify/elicit significant medical events, including but not limited to hematologic, malignant, autoimmune, neurologic, and hepatic events.
- Conditions
- Hepatitis C
- Keywords
- Adeno-associated viral vectors, Adeno-associated virus, AAV, AAV8, ddRNAi, shRNA, RNAi, Hepatitis, Chronic Hepatitis C, HCV, CHC, Genotype 1
- Medical subject headings
- Hepatitis C, Hepatitis, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dosed subjects | There is no intervention. This is a observational study monitoring subjects that were dosed with TT-034 in the Tacere B2801001 study, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long Term Safety as measured through an assessment of adverse events
The primary objective is to assess the long-term safety of TT-034 administered in subjects with CHC through an assessment of adverse events with a focus on hematologic, malignant, autoimmune, neurologic and hepatic events.
Measured: 4.5 years
Secondary outcomes (1)
Long Term Viral Load
The secondary objective is to monitor long-term HCV viral load, as available, of subjects who have received TT-034.
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startNov 2014
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
Why it stopped: Long term safety follow-up no longer required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tacere Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Suhy, PhD, Study director, Tacere Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315638
- Sponsor's protocol ID
- B2801002
- Status last verified
- Sep 2018
- First submitted
- 5 Dec 2014
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up to Study Protocol B2801001, A Phase I/II, Open-Label Dose Escalation Study to Evaluate the Safety and Efficacy of Single Doses of TT-034 in Patients With Chronic Hepatitis C [CHC] Infection
- ClinicalTrials.gov ID
- NCT02315638
- Acronym / sponsor ID
- B2801002
- Conditions
- Hepatitis C
- Keywords
- Adeno-associated viral vectors, Adeno-associated virus, AAV, AAV8, ddRNAi, shRNA, RNAi, Hepatitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Long term safety follow-up no longer required
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Tacere Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 12 Dec 2014 (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.
This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years.
Detailed description
The main purpose of this follow-up study is to detect events suggestive of delayed adverse effects of the study drug by review of clinical histories and discussion with subjects to identify/elicit significant medical events, including but not limited to hematologic, malignant, autoimmune, neurologic, and hepatic events.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dosed subjects | – | –There is no intervention. This is a observational study monitoring subjects that were dosed with TT-034 in the Tacere B2801001 study, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is comprised of subjects that were enrolled in Study B2801001 and who received a dose of TT-034.
Key inclusion criteria (2 listed)
- Prior enrollment in Study B2801001 and dosing with TT-034
- An informed consent form for this study signed and dated by the subject or a legally acceptable representative
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this follow-up study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long Term Safety as measured through an assessment of adverse events
Time frame: 4.5 years
The primary objective is to assess the long-term safety of TT-034 administered in subjects with CHC through an assessment of adverse events with a focus on hematologic, malignant, autoimmune, neurologic and hepatic events.
1 secondary outcome
Long Term Viral Load
Time frame: 4.5 years
Results and safety
The study was stopped early (reason given: Long term safety follow-up no longer required). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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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.
David Suhy, PhD study director
Tacere Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Tacere Therapeutics, Inc. at 1 site 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 2 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: stopped early, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: Long term safety follow-up no longer required). Results are not available in the source record.
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?
Long Term Safety as measured through an assessment of adverse events (time frame: 4.5 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 26 Sep 2018.