Back to results

Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Primary Purpose

African Trypanosomiasis

Status

Completed

Phase

Phase 2

Locations

Congo

Study Type

Interventional

Intervention

DB289

Pentamidine

About this trial

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

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Patient is 15 to 50 years old
Patient has a minimal weight of 35 kilograms
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).
Patient has understood and 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 WBC count of > 5mm-1
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)
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. -

Sites / Locations

CDTC Maluku
Vanga Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DB289

Pentamidine

Arm Description

Pafuramidine maleate (DB289), 100 mg BID orally

Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM

Outcomes

Primary Outcome Measures

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

The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00803933

First Posted

December 4, 2008

Last Updated

December 5, 2008

Sponsor

Immtech Pharmaceuticals, Inc

Collaborators

Bill and Melinda Gates Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00803933

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

February 2003 (undefined)

Primary Completion Date

February 2004 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Immtech Pharmaceuticals, Inc

Collaborators

Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

African Trypanosomiasis

Keywords

first stage, Trypanosoma brucei gambiense, T. b. gambiense, sleeping sickness, First stage T. b. gambiense sleeping sickness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DB289

Arm Type

Experimental

Arm Description

Pafuramidine maleate (DB289), 100 mg BID orally

Arm Title

Pentamidine

Arm Type

Active Comparator

Arm Description

Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM

Intervention Type

Drug

Intervention Name(s)

DB289

Other Intervention Name(s)

pafuramidine maleate

Intervention Description

Pafuramidine maleate (DB289), 100 mg BID orally

Intervention Type

Drug

Intervention Name(s)

Pentamidine

Intervention Description

Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Title

The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period.

Time Frame

12 day

Secondary Outcome Measure Information:

Title

Time Frame

12 day

Title

Time Frame

6, 12, 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Patient is 15 to 50 years old Patient has a minimal weight of 35 kilograms 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): 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 is an acceptable method) from the day of consent on until the end of the observation period (day 7). Patient has understood and 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 WBC count of > 5mm-1 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) 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

Victor Kande, MD

Organizational Affiliation

Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine

Official's Role

Principal Investigator

Facility Information:

Facility Name

CDTC Maluku

City

Gombe

State/Province

Kinshasa

Country

Congo

Facility Name

Vanga Hospital

City

Gombe

State/Province

Kinshasa

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

derived

Learn more about this trial

Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

We'll reach out to this number within 24 hrs