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A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Primary Purpose

Trypanosomiasis, African

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DB289
Sponsored by
Immtech Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trypanosomiasis, African focused on measuring first stage, T.b. gambiense, sleeping sickness, Patients with first stage T.b. gambiense sleeping sickness

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph and less than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination
  2. Patient is 16 years old or more
  3. Patient has a minimal weight of 45 kilograms
  4. If patient is female of child bearing potential (a women will be considered of non-child bearing potential only if she has been post menopausal for over 2 years or has had a hysterectomy), she is not lactating, she had a negative urine pregnancy test result within 24 hours prior to DB289 treatment and she agrees to use a medically proven method of contraception (abstinence from sexual intercourse acceptable) from the day of consent on until 7 Days after DB289 treatment completion (Study Day 12).
  5. Patient has signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent

Exclusion Criteria:

  1. The patient has late stage T.b. gambiense infection i.e. presence of parasite in the CSF upon microscopic examination, or a positive (titer greater than 1/4) latex / IgM test, or a positive latex / T.b.g.
  2. Active clinically relevant medical conditions that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases or significant ECG anomaly such as elongated QTc (corrected) interval above 430 msec for men or above 450 msec for women, diabetes, thyroid diseases, gout, infection including known HIV infection, CNS trauma or seizure disorders.

  3. Clinically significant abnormal laboratory value at screening including:

    • Prothrombin Time > 1.25 times upper limit of normal (ULN)
    • Liver enzyme AST and ALT > 2 times ULN
    • Total bilirubin > 1.5 times ULN
    • Serum Creatinine > 1.5 times ULN
  4. Traumatic lumbar puncture (i.e. red blood cells visible in CSF)
  5. Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)
  6. Withdrawal of consent at any time during the study
  7. Any condition which compromises ability to communicate with the investigator as required for the completion of this study.
  8. The subject has been previously treated for African Trypanosomiasis.
  9. The subject has been previously enrolled in the study.

Sites / Locations

  • Laboratory of Reference and Investigation, Viana, ICCT
  • Programme National de Lutte contre la Trypanosomiase

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DB289

Arm Description

Outcomes

Primary Outcome Measures

The primary efficacy endpoint is the parasitological cure 24 hours after completion of treatment.
The primary outcome measure for safety analysis will be the rate of occurrence of Grade 3 or higher adverse events during the observation period.

Secondary Outcome Measures

A secondary endpoint is the parasitological cure 3, 6, 12, 24 months after completion of treatment.
The secondary outcome measure will be the incidence rate of adverse events (all Grades combined) during the observation period (as compared to literature values for pentamidine).

Full Information

First Posted
December 3, 2008
Last Updated
December 4, 2008
Sponsor
Immtech Pharmaceuticals, Inc
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00802594
Brief Title
A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Official Title
Phase II A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Immtech Pharmaceuticals, Inc
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There are currently no drugs which might be used as a tool to support disease control that is easily administered and has low toxicity. This study aims to assess the efficacy of DB289, a new, oral drug for treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of more than a dozen partners from academia, industry, and the Ministries of Health of Angola and the Democratic Republic of Congo.
Detailed Description
This is a single-center, open label, non-controlled Phase IIa trial. Patients with first stage T.b. gambiense sleeping sickness will receive 100 mg of DB289 orally twice a day for 5 days. Subjects meeting entry criteria will be enrolled at a single site. A total of 30 patients will be enrolled in this trial. Enrollment is planned to begin third quarter 2001 and be completed in 2-3 months. The study will be conducted at the Trypanosomiasis Reference Center, Viana (ICCT), Angola, and at the Trypanosomiasis Treatment Center in Maluku, Congo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trypanosomiasis, African
Keywords
first stage, T.b. gambiense, sleeping sickness, Patients with first stage T.b. gambiense sleeping sickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DB289
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DB289
Other Intervention Name(s)
pafuramidine maleate
Intervention Description
A single 100 mg DB289 capsule will be taken by mouth twice a day, morning and evening. Drug is to be taken with a glass of water within 15 minutes of the completion of meal.
Primary Outcome Measure Information:
Title
The primary efficacy endpoint is the parasitological cure 24 hours after completion of treatment.
Time Frame
Day 7
Title
The primary outcome measure for safety analysis will be the rate of occurrence of Grade 3 or higher adverse events during the observation period.
Time Frame
Day 12
Secondary Outcome Measure Information:
Title
A secondary endpoint is the parasitological cure 3, 6, 12, 24 months after completion of treatment.
Time Frame
3, 6, 12, 24 months
Title
The secondary outcome measure will be the incidence rate of adverse events (all Grades combined) during the observation period (as compared to literature values for pentamidine).
Time Frame
Day 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph and less than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination Patient is 16 years old or more Patient has a minimal weight of 45 kilograms If patient is female of child bearing potential (a women will be considered of non-child bearing potential only if she has been post menopausal for over 2 years or has had a hysterectomy), she is not lactating, she had a negative urine pregnancy test result within 24 hours prior to DB289 treatment and she agrees to use a medically proven method of contraception (abstinence from sexual intercourse acceptable) from the day of consent on until 7 Days after DB289 treatment completion (Study Day 12). Patient has signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent Exclusion Criteria: The patient has late stage T.b. gambiense infection i.e. presence of parasite in the CSF upon microscopic examination, or a positive (titer greater than 1/4) latex / IgM test, or a positive latex / T.b.g. Active clinically relevant medical conditions that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases or significant ECG anomaly such as elongated QTc (corrected) interval above 430 msec for men or above 450 msec for women, diabetes, thyroid diseases, gout, infection including known HIV infection, CNS trauma or seizure disorders. Clinically significant abnormal laboratory value at screening including: Prothrombin Time > 1.25 times upper limit of normal (ULN) Liver enzyme AST and ALT > 2 times ULN Total bilirubin > 1.5 times ULN Serum Creatinine > 1.5 times ULN Traumatic lumbar puncture (i.e. red blood cells visible in CSF) Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8) Withdrawal of consent at any time during the study Any condition which compromises ability to communicate with the investigator as required for the completion of this study. The subject has been previously treated for African Trypanosomiasis. The subject has been previously enrolled in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Burri, MSc, PhD
Organizational Affiliation
Swiss Tropical & Public Health Institute
Official's Role
Study Director
Facility Information:
Facility Name
Laboratory of Reference and Investigation, Viana, ICCT
City
Bairro Ingombota
State/Province
Luanda
ZIP/Postal Code
CP 2657-C
Country
Angola
Facility Name
Programme National de Lutte contre la Trypanosomiase
City
Kinshasa
State/Province
Gombe
Country
Congo

12. IPD Sharing Statement

Citations:
PubMed Identifier
26881924
Citation
Burri C, Yeramian PD, Allen JL, Merolle A, Serge KK, Mpanya A, Lutumba P, Mesu VK, Bilenge CM, Lubaki JP, Mpoto AM, Thompson M, Munungu BF, Manuel F, Josenando T, Bernhard SC, Olson CA, Blum J, Tidwell RR, Pohlig G. Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies. PLoS Negl Trop Dis. 2016 Feb 16;10(2):e0004362. doi: 10.1371/journal.pntd.0004362. eCollection 2016 Feb.
Results Reference
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A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

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