Trypanosomiasis, AfricanPhase 2NCT00802594
A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
A Phase 2 study testing DB289 in people with Trypanosomiasis, African, run by Immtech Pharmaceuticals, Inc at 2 sites in 2 countries.
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 16 years and older
- Conditions the study is for
- Trypanosomiasis, African
- What is being tested?
- DB289
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2001to Nov 2004
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older 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 and less than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination
- Patient is 16 years old or more
- Patient has a minimal weight of 45 kilograms
- 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).
- Patient has 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 positive (titer greater than 1/4) latex / IgM test, or a positive latex / T.b.g.
- 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.
- 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
Show all 13Show fewer
- Serum Creatinine > 1.5 times ULN
- Traumatic lumbar puncture (i.e. red blood cells visible in CSF)
- 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 2 countries.
2 sites in 2 countries
Angola1 site
Laboratory of Reference and Investigation, Viana, ICCT
Bairro Ingombota, Luanda Province, CP 2657-C
Republic of the Congo1 site
Programme National de Lutte contre la Trypanosomiase
Kinshasa, Gombe
About this study
Official title: Phase II A 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 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.
Read the 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.
- Conditions
- Trypanosomiasis, African
- Being tested
- DB289
- Keywords
- first stage, T.b. gambiense, sleeping sickness, Patients with 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
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.
| Study group | Role | What they receive |
|---|---|---|
| DB289 | Experimental | Not described Receives: Drug: DB289 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the parasitological cure 24 hours after completion of treatment.
Measured: 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.
Measured: Day 12
Secondary outcomes (2)
A secondary endpoint is the parasitological cure 3, 6, 12, 24 months after completion of treatment.
Measured: 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).
Measured: Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startAug 2001
- Primary completionAug 2002
- Study completionNov 2004
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 Trypanosomiasis, AfricanStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immtech Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Investigators
- Christian Burri, MSc, PhD, Study director, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802594
- Sponsor's protocol ID
- 289-C-003
- Status last verified
- Dec 2008
- First submitted
- 3 Dec 2008
- Last updated
- 5 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 5 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
- ClinicalTrials.gov ID
- NCT00802594
- Acronym / sponsor ID
- 289-C-003
- Conditions
- Trypanosomiasis, African
- Keywords
- first stage, T.b. gambiense, sleeping sickness, Patients with first stage T.b. gambiense sleeping sickness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Immtech Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Aug 2001
- Primary completion
- Aug 2002 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 5 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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DB289 | Experimental | Drug: DB289 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Patient is 16 years old or more
- Patient has a minimal weight of 45 kilograms
- 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).
- Patient has signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent
Key exclusion criteria (13 listed)
- 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.
- 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.
- Clinically significant abnormal laboratory value at screening including:
- Traumatic lumbar puncture (i.e. red blood cells visible in CSF)
- Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)
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 maleateA 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. | Drug | DB289 |
Primary outcome
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
2 secondary outcomes
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
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 5 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.
Christian Burri, MSc, PhD study director
Swiss Tropical & Public Health Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DB289 in people with Trypanosomiasis, African, run by Immtech Pharmaceuticals, Inc at 2 sites in 2 countries.
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 5 inclusion and 13 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 5 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 Angola, 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 is the parasitological cure 24 hours after completion of treatment. (time frame: Day 7). 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 NCT00802594, 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 5 Dec 2008.