NCT04133649

Brief Summary

Using gene therapy to express active telomerase (hTERT) in humans has the potential to treat many of the age related diseases, including Aging itself. This study will entail treating subjects with hTERT delivered via transduction using AAV. The goal is to extend the telomeres to prevent, delay, or even reverse Aging.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

October 16, 2019

Last Update Submit

December 6, 2019

Conditions

Aging

Keywords

AgingGene therapyAAVhTerttelomereTelomerase

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Incidence of serious adverse events and adverse events throughout the study

    12 months

Secondary Outcomes (1)

  • hTERT expression and telomerase activity

    12 months

Study Arms (1)

subjects treated with LGT

EXPERIMENTAL

Subjects will be treated with a single IV dose of LGT (AAV-hTERT)

Drug: AAV-hTERT

Interventions

AAV-hTERTDRUG

subjects will receive a single LGT (AAV-hTERT) treatment via IV administration

Also known as: LGT
subjects treated with LGT

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 45 years or older.
  • Subjects, or their authorized representatives, must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date in the Informed Consent Form (ICF).
  • Women must undergo a negative serum pregnancy test at the screening assessment.
  • Subjects, or their representatives, must be able to communicate effectively with the study staff.
  • Subjects, or their authorized representatives, must certify that they are able and willing to follow all protocol requirements and study restrictions.

You may not qualify if:

  • Subjects are not eligible for the study if they meet any of the following criteria at the screening visit, unless otherwise specified.
  • Subjects who have a history of allergy, hypersensitivity, or intolerance to any medications, components, or excipients of the investigational product, which cannot be resolved by the staff conducting the study.
  • Female subjects who are pregnant, expected to become pregnant, or lactating/nursing.
  • Subjects who are sexually active and who are unwilling or unable to use a method of effective contraception (e.g., hormonal and/or barrier) during their participation in the study.
  • Subjects who are intolerant of, or do not wish to receive, IV or IT injections.
  • Subjects who are currently alcoholics and/or use psychoactive substances.
  • Subjects who cannot tolerate venipuncture and/or venous access.
  • Subjects who have donated or had a significant loss of whole blood (480 ml or more) within 30 days, or donated plasma or platelets within 14 days prior to screening.
  • Subjects who have received blood or blood products within 30 days prior to screening.
  • Subjects who have been treated with another research product 30 days prior to the screening assessment, or plan to participate in another clinical trial, while in this study if in the opinion of the principal investigator, may place the subject at risk due to participation in the study, or may influence the results of the study or the subject's ability to complete the study. If more than 30 days have passed since participation in another clinical trial, the study staff must ensure that the subject has recovered from any adverse event (AE) associated with the research product used.
  • Subjects who have a history or evidence of active infection or febrile illness within 7 days prior to the screening assessment.
  • Subjects who have a history of any other clinically significant disease or disorder that, in the opinion of the principal investigator, may place the subject at risk due to participation in the study, or may influence the results of the study or the subject's ability to complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IPS Arcasalud SAS

Zipaquirá, Cundinamarca, 250251, Colombia

RECRUITING

Study Officials

  • Winston Pernet, MD

    IPS Arcaslud SAS

    STUDY CHAIR

Central Study Contacts

Jeff Mathis, PhD

CONTACT

1 785 4100223jmathis@libellagt.com

Osvaldo Martinez-Clark

CONTACT

1 786 4717814ozclark@libellagt.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 21, 2019

Study Start

October 17, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)