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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

Quick Stats
Studies 759
Trials 63
Unknown PHASE1, PHASE2 INTERVENTIONAL NCT00580450

Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this trial is to determine safety and efficacy of 16 weeks treatment with thymosin alpha 1 given at 1.6 mg dose once daily by subcutaneous injection in adult patients with hematological undergone allogenic bone marrow transplantation and CMV positive. The efficacy will be explored assessing the ability of thymosin alpha1 to prevent the infection complications.

Detailed Description

This is an open label, monocenter, explorative study . A total of 9 patients will be included in the study in three sequential cohort of 3 patients each. Patients will enter into the study after meeting the inclusion and exclusion criteria and signing the Informed Consent Form. The first three patients will be treated for 16 weeks starting 40 days after transplantation; if all three patients will complete the treatment period without any serious treatment related adverse event then the recruitment of second cohort of patients will be opened and patients treated starting from 20 days after transplantation. The same procedure will be applied for the third cohort of patients starting treatment from day of transplantation.

Interventions

Name: Thymosin alpha 1
Type: DRUG
Description: 1.6 mg sc once a day for 16 weeks

Primary Outcomes

Measure: Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD.
TimeFrame: 3 years
Description:

Trial Information

NCT ID

NCT00580450

Status

Unknown

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

University Of Perugia

Last Updated

December 15, 2025