Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

African Trypanosomiasis Clinical Trial

Official title:

Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803933
• Other study ID #: 289-C-006
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2008
• Last updated: December 5, 2008
• Start date: February 2003
• Est. completion date: June 2005

Study information

• Verified date: December 2008
• Source: Immtech Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2005
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• African Trypanosomiasis
• Trypanosomiasis
• Trypanosomiasis, African

Intervention

Drug:
• DB289
Pafuramidine maleate (DB289), 100 mg BID orally
• Pentamidine
Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM

Locations

Country	Name	City	State
Congo	CDTC Maluku	Gombe	Kinshasa
Congo	Vanga Hospital	Gombe	Kinshasa

Sponsors (2)

Lead Sponsor	Collaborator
Immtech Pharmaceuticals, Inc	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Congo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.		3 months	No
Primary	The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period.		12 day	Yes
Secondary	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.		12 day	Yes
Secondary	The number and percentage of subjects with parasitological cure, subjects with confirmed (parasitological) treatment failure, and subjects with suspected treatment failure at 6, 12, and 24 months after completion of treatment.		6, 12, 24 months	No