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NCT06817590 · ClinicalTrials.gov registry record · Phase 1

Nucleoside Therapy in Patients With Telomere Biology Disorders

A Phase 1 study of Dyskeratosis Congenita and Telomere Biology Disorders, sponsored by Suneet Agarwal.

Recruiting
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT06817590: Recruiting Phase 1 study of Dyskeratosis Congenita and Telomere Biology Disorders, sponsored by Suneet Agarwal.

NCT06817590 is a Phase 1 study of Dyskeratosis Congenita and Telomere Biology Disorders that is actively recruiting participants, run by Suneet Agarwal. The registered enrollment target is 36 participants, below the 849-participant average among 7 other Dyskeratosis Congenita trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06817590, a Phase 1 study of Dyskeratosis Congenita and Telomere Biology Disorders, is actively recruiting participants, sponsored by Suneet Agarwal.

RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical trial is to learn if a combination therapy of deoxycytidine (dC) plus deoxythymidine (dT) is safe in patients with telomere biology disorders. The main questions it aims to answer are: * Is the therapy safe with tolerable side effects in patients with telomere biology disorders? * Are problems with the bone marrow or blood or lungs changed after 6 months of dC+dT treatment in patients with telomere biology disorders? Participants will: * Take study drug by mouth three times daily for 24 weeks * Make approximately 2 visits to Boston Children's Hospital during the 24 weeks: once at the beginning of treatment and once at the end of treatment. * Go to a lab for a blood draw an additional 6 times during treatment. * Have 9 phone calls with a research nurse, including one 4 weeks after treatment ends. * Keep a diary to track doses of study drug that were taken or missed.

Primary Outcome

Proportion of study participants with grade 3 or higher treatment-related diarrhea refractory to dose adjustments

Conditions Studied

Dyskeratosis Congenita Telomere Biology Disorders Hoyeraal-Hreidarsson Syndrome Revesz Syndrome Telomere Biology Disorders With Bone Marrow Failure Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder) Pulmonary Fibrosis, Familial (Telomere Biology Disorder)

Interventions

  • DRUG deoxycytidine
  • DRUG deoxythymidine

Study Locations (1)

Massachusetts

  • Boston Childrens Hospital - Boston

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2025-09-29
Est. Completion 2029-06
Phase Phase 1
Suneet Agarwal

1 total trials

What NCT06817590 shows while recruiting

NCT06817590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 849-participant average among 7 other Dyskeratosis Congenita trials with a reported enrollment target (96% lower).

The record links to 7 conditions, with Dyskeratosis Congenita appearing as the primary indexed condition, and to 2 interventions - of which deoxycytidine is the first listed.

NCT06817590 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06817590 about?

NCT06817590 is a clinical study titled "Nucleoside Therapy in Patients With Telomere Biology Disorders". The goal of this clinical trial is to learn if a combination therapy of deoxycytidine (dC) plus deoxythymidine (dT) is safe in patients with telomere biology disorders. The main questions it aims to answer are: * Is the therapy safe with tolerable side effects in patients with telomere biology diso...

What is the current status of trial NCT06817590?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-09-29. Estimated completion is 2029-06.

What conditions does trial NCT06817590 study?

This clinical trial studies the following conditions: Dyskeratosis Congenita, Telomere Biology Disorders, Hoyeraal-Hreidarsson Syndrome, Revesz Syndrome, Telomere Biology Disorders With Bone Marrow Failure.

What interventions are being tested in trial NCT06817590?

The interventions under investigation include: deoxycytidine (DRUG), deoxythymidine (DRUG).

Who is sponsoring clinical trial NCT06817590?

This trial is sponsored by Suneet Agarwal, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06817590 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06817590

Source: ClinicalTrials.gov NCT06817590, the US trial registry maintained by the National Library of Medicine. NCT06817590 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.