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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00802594
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : December 5, 2008
Bill and Melinda Gates Foundation
Information provided by:
Immtech Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE December 3, 2008
First Posted Date  ICMJE December 5, 2008
Last Update Posted Date December 5, 2008
Study Start Date  ICMJE August 2001
Actual Primary Completion Date August 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2008)
  • The primary efficacy endpoint is the parasitological cure 24 hours after completion of treatment. [ Time Frame: Day 7 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2008)
  • A secondary endpoint is the parasitological cure 3, 6, 12, 24 months after completion of treatment. [ Time Frame: 3, 6, 12, 24 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Official Title  ICMJE Phase II A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Trypanosomiasis, African
Intervention  ICMJE Drug: DB289
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.
Other Name: pafuramidine maleate
Study Arms  ICMJE Experimental: DB289
Intervention: Drug: DB289
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2008)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion Date August 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Angola,   Congo
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00802594
Other Study ID Numbers  ICMJE 289-C-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christian Burri, MSc, PhD., Swiss Tropical Institute
Study Sponsor  ICMJE Immtech Pharmaceuticals, Inc
Collaborators  ICMJE Bill and Melinda Gates Foundation
Investigators  ICMJE
Study Director: Christian Burri, MSc, PhD Swiss Tropical & Public Health Institute
PRS Account Immtech Pharmaceuticals, Inc
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP