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Long-Term Follow-Up Safety Monitoring of Patients Dosed in the First-in-Man Phase I/II Study of TT-034.

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ClinicalTrials.gov Identifier: NCT02315638
Recruitment Status : Terminated (Long term safety follow-up no longer required)
First Posted : December 12, 2014
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Tacere Therapeutics, Inc.

Brief 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.

Condition or disease
Hepatitis C

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.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : November 2014
Actual Primary Completion Date : September 24, 2018
Actual Study Completion Date : September 24, 2018

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Group/Cohort
Dosed subjects
There is no intervention. This is a observational study monitoring subjects that were dosed with TT-034 in the Tacere B2801001 study,



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Long Term Viral Load [ Time Frame: 4.5 years ]
    The secondary objective is to monitor long-term HCV viral load, as available, of subjects who have received TT-034.


Biospecimen Retention:   Samples Without DNA
Blood samples will be collected and archived for further testing, should future data suggest that it is clinically or scientifically indicated.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is comprised of subjects that were enrolled in Study B2801001 and who received a dose of TT-034.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • There are no specific exclusion criteria for this follow-up study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315638


Locations
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United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Tacere Therapeutics, Inc.
Investigators
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Study Director: David Suhy, PhD Tacere Therapeutics, Inc.

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Responsible Party: Tacere Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02315638     History of Changes
Other Study ID Numbers: B2801002
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Keywords provided by Tacere Therapeutics, Inc.:
Adeno-associated viral vectors
Adeno-associated virus
AAV
AAV8
ddRNAi
shRNA
RNAi
Hepatitis
Chronic Hepatitis C
HCV
CHC
Genotype 1

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections