International randomized controlled phase III trial of DB289 versus pentamidine for the treatment of first stage Human African Trypanosomiasis (HAT)

Phase 3

Completed

• Conditions: Human African Trypanosomiasis (HAT) or sleeping sickness; Infections and Infestations; Human African Trypanosomiasis (HAT)

• Registration Number: ISRCTN85534673
• Lead Sponsor: Immtech Pharmaceuticals, Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. The patient has first stage T. b. gambiense infection, i.e. parasitologically confirmed infection in the blood or lymph node aspirate and White Blood Cell count (WBC) less than or equal to 5 mm^3 detected in the CerebroSpinal Fluid (CSF) by microscopic examination.
2. Patient is male or female 12 years of age or older and more than or equal to 30 kg.

Exclusion Criteria

1. The patient has possible or confirmed second stage T. b. gambiense infection, i.e. presence of parasite in the CSF upon microscopic examination or a WBC count in the CSF of more than 5 mm^-3
2. Active clinically relevant medical conditions that in the Investigator's opinion may jeopardise subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, infection including known Human Immunodeficiency Virus (HIV) infection, Central Nervous System (CNS) trauma or seizure disorders
3. Coma Score of less than nine on the Glasgow Coma Scale

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy variable will be the combined rate of clinical and parasitological cure at the Test of Cure evaluation (12 month evaluation) in the Per Protocol dataset.

Secondary Outcome Measures

Name	Time	Method
Parasitological cure, clinical cure, probable relapse, relapse and death rates at the End of Treatment and at the 3, 6, 18 and 24 month evaluations will also be determined.