African TrypanosomiasisPhase 2NCT00803933
Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
A Phase 2 study testing DB289 and Pentamidine in people with African Trypanosomiasis, run by Immtech Pharmaceuticals, Inc at 2 sites in Republic of the Congo.
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. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- African Trypanosomiasis
- What is being tested?
- DB289 and Pentamidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesRepublic of the Congo
- Study dates
- Feb 2003to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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. -
Trial locations and contacts
2 sites in 1 country.
Republic of the Congo2 sites
CDTC Maluku
Gombé, Kinshasa
Vanga Hospital
Gombé, Kinshasa
About this study
Official title: Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
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.
- Conditions
- African Trypanosomiasis
- Being tested
- DB289, Pentamidine
- Keywords
- first stage, Trypanosoma brucei gambiense, T. b. gambiense, sleeping sickness, First stage T. b. gambiense sleeping sickness
- Medical subject headings
- Trypanosomiasis, African
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB289Drug
Also called pafuramidine maleate
Pafuramidine maleate (DB289), 100 mg BID orally
PentamidineDrug
Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
| Study group | Role | What they receive |
|---|---|---|
| DB289 | Experimental | Pafuramidine maleate (DB289), 100 mg BID orally Receives: Drug: DB289 |
| Pentamidine | Active comparator | Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM Receives: Drug: Pentamidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.
Measured: 3 months
The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period.
Measured: 12 day
Secondary outcomes (2)
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.
Measured: 12 day
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.
Measured: 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startFeb 2003
- Primary completionFeb 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for African TrypanosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immtech Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Investigators
- Victor Kande, MD, Principal investigator, Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803933
- Sponsor's protocol ID
- 289-C-006
- Status last verified
- Dec 2008
- First submitted
- 4 Dec 2008
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26881924
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
- ClinicalTrials.gov ID
- NCT00803933
- Acronym / sponsor ID
- 289-C-006
- Conditions
- African Trypanosomiasis
- Keywords
- first stage, Trypanosoma brucei gambiense, T. b. gambiense, sleeping sickness, First stage T. b. gambiense sleeping sickness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Immtech Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Feb 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DB289 | Experimental | Drug: DB289Pafuramidine maleate (DB289), 100 mg BID orally |
| Pentamidine | Active comparator | Drug: PentamidinePentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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):
- Patient has understood and signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB289Also: pafuramidine maleatePafuramidine maleate (DB289), 100 mg BID orally | Drug | DB289 |
| PentamidinePentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM | Drug | Pentamidine |
Primary outcome
The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.
Time frame: 3 months
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
2 secondary outcomes
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.
Time frame: 12 day
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.
Time frame: 6, 12, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2008.
- Derived from this study: PubMed 26881924Burri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Kande, MD principal investigator
Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DB289 and Pentamidine in people with African Trypanosomiasis, run by Immtech Pharmaceuticals, Inc at 2 sites in Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2008.