Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06060600
Other study ID # PAX-HAT-301
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2023
Est. completion date August 2, 2023

Study information

Verified date September 2023
Source Paxmedica
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study will include TBR HAT patients treated with suramin between 2000 and 2020 at three sites in Uganda and Malawi A natural history cohort composed of source data from approximately 200 patients from a published epidemiological study will be used as a comparator. This study's objectives are to evaluate the efficacy and safety of suramin in the Stage 1 treatment of TBR HAT.


Description:

The study will include TBR HAT patients treated with suramin between 2000 and 2020 at three sites in Uganda and Malawi (e.g., the retrospective suramin-treated cohort). The study will include all the approximately 145 patients who are deemed eligible through chart review and who have sufficient data. A natural history cohort composed of source data from approximately 200 patients from a published epidemiological study will be used as a comparator. The primary objective is to determine whether standard of care treatment with suramin, as currently practiced in Uganda and Malawi, leads to better health outcomes in patients with S1 TBR HAT than observed in a natural history cohort with source data from a published epidemiologic study.


Read more »

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States PaxMedica Tarrytown New York

Sponsors (1)

Lead Sponsor Collaborator
Paxmedica

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary efficacy endpoint is survival of patients treated with suramin compared to the natural history cohort. The primary efficacy analysis will compare the proportion alive and not meeting any of the following criteria
Death (both cohorts).
Progression from Stage 1 to Stage 2 TBR HAT as defined by meeting any of the following:
presence of TBR trypanosomes in the cerebrospinal fluid (CSF)
abnormal symptoms .
presence of TBR HAT symptoms for more than 2 months
Use of melarsoprol for clinical worsening or treatment failure
Moribund status
30 Days
Secondary The secondary objective is to describe the safety and tolerability of suramin. • Incidence of adverse events. 30 Days
See also
  Status Clinical Trial Phase
Completed NCT03974178 - Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense Phase 2/Phase 3