Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Brief Title

Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Official Title

Phase II b 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 that are easily administered and have low toxicity, and might thus be
      used as tools to support disease control.

      This study aims to compare the safety and efficacy of DB289, a new, orally administered
      dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping
      sickness. The project will be executed in the framework of an international consortium
      consisting of several partners from academia, industry and from the Democratic Republic of
      Congo Ministries of Health.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.

Secondary Outcome

 The secondary outcome measure was the incidence rate of adverse events (all Grades combined) during the 7- to 9-day observation period in Treatment Sequence 1 and during the 12-day observation period in Treatment Sequence 2.

Condition

African Trypanosomiasis

Intervention

DB289

Study Arms / Comparison Groups

 DB289
Description:  Pafuramidine maleate (DB289), 100 mg BID orally

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

111

Start Date

February 2003

Completion Date

June 2005

Primary Completion Date

February 2004

Eligibility Criteria

        Inclusion Criteria:

          1. The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed
             infection in the blood or lymph node aspirate and greater than or equal to 5 WBC mm-3
             detected in the CSF by microscopic examination

          2. Patient is 15 to 50 years old

          3. Patient has a minimal weight of 35 kilograms

          4. If the 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):

               1. she is not lactating,

               2. she had a negative urine pregnancy test result within 24 hours prior to DB289
                  treatment and

               3. she agrees to use a medically proven method of contraception (abstinence from
                  sexual intercourse is an acceptable method) from the day of consent on until the
                  end of the observation period (day 7).

          5. Patient has understood and 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 WBC count of > 5mm-1

          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, diabetes, thyroid diseases, gout, infection including known
             HIV infection, CNS trauma or seizure disorders (A list of typical signs and symptoms
             is provided for guidance of the investigator in attachment 1)

          3. Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)

          4. Withdrawal of consent at any time during the study

          5. Any condition which compromises ability to communicate with the investigator as
             required for the completion of this study.

          6. The subject has been previously treated for African Trypanosomiasis.

          7. The subject has been previously enrolled in the study. -
      

Gender

All

Ages

15 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Victor Kande, MD, , 

Location Countries

Congo

Location Countries

Congo

Administrative Informations


NCT ID

NCT00803933

Organization ID

289-C-006



Study Sponsor

Immtech Pharmaceuticals, Inc

Collaborators

 Bill and Melinda Gates Foundation

Study Sponsor

Victor Kande, MD, Principal Investigator, Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine


Verification Date

December 2008