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A Clinical Study of NAD in the Treatment of Immune Thrombocytopenia

Plain-language guide to NCT06776510: phase 1, phase 2 interventional trial of NAD+, 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06776510
Phase
phase 1, phase 2
Status
recruiting participants
Start
2025-01-15
Completion (planned or actual)
2025-12-01
Participants
20 (estimated)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Immune Thrombocytopenia; Treatment
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test NAD+.

It had 1 arm (groups): Experimental: (experimental).

Nicotinamide adenine dinucleotide/nicotinamide mononucleotide.

The registry classes the interventions as drug.

More on the Plan

Conventional treatment of adult ITP includes first-line glucocorticoid and immunoglobulin therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.).

The main pathogenesis of ITP is the loss of platelet autoantigen immune tolerance, which leads to abnormal activation of humoral and cellular immunity.

It is characterized by antibody mediated platelet destruction and insufficient platelet production by megakaryocytes.

The residual long-term autoreactive plasma cells may be a source of therapeutic resistance to autoimmune cytopenia.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 and above, male or female;. Conform to the diagnostic criteria of immune Thrombocytopenia (ITP) ≥3 months;. ECOG physical state score ≤ 2 points;. Signed and dated written informed consent.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: A history of undergoing allogeneic stem cell transplantation or organ transplantation; positive for hiv antibodies or syphilis antibodies; subjects with mental disorders who are unable to provide informed consent or participate in the trial and follow-up properly.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when NAD+ was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-01-15 with completion listed for 2025-12-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): incidence of treatment-emergent Adverse Events and TRAE (time frame: [Time Frame: 8 weeks]).

It also tracked 8 secondary outcomes, for example Duration from treatment initiation to platelet count ≥30×10^9/L (at least two times of baseline platelet count) and ≥50×10^9/L, Platelet count at each visit time point, Emergency treatment, Cumulative weeks of platelet ≥30×10^9/L (at least two times of baseline platelet count) and platelet ≥50×10^9/L, The change in bleeding score before treatment and 2 weeks after treatment assessed using the world health organization (WHO) bleeding scale and The response rate within 4 weeks.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of NAD+ in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.