Malaria, FalciparumPhase 1/2NCT01442168
Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
A Phase 1/2 study testing Sevuparin sodium + atovaquone/proquanil and atovaquone/proquanil in people with Malaria, Falciparum, run by Modus Therapeutics AB at 3 sites in Thailand.
Trial summary
The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Sevuparin sodium + atovaquone/proquanil and atovaquone/proquanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesThailand
- Study dates
- Sep 2011to Jan 2014
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of a single species (P. falciparum)
- Counts of asexual forms of P. falciparum: 10 000- 100 000/ul with or without gametocytaemia
- Presence of fever defined as > 38°C tympanic temperature or a history of fever within the last 24 hours
Who cannot join
- Mixed infection with other Plasmodium species
- Any criteria of severe or complicated malaria as defined by the WHO, 2010
- Use of high doses aspirin (more than 100 mg/day) or dual anti-platelet therapy or use of heparin,Low Molecular Weight Heparin (LMWH) or warfarin
- Presence of significant anemia as defined by Hb <8 g/dL or Hct < 25%
- A platelet count < 50,000/μL
- Presence of febrile conditions caused by diseases other than malaria
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Hospital for Tropical Diseases
Bangkok
Mae Ramat Hospital
Mae Ramat, Changwat Tak
Maesot General hospital
Mae Sot, Changwat Tak
About this study
Official title: A Phase I/II, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study of Sevuparin/DF02, as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation.
The study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).
- Conditions
- Malaria, Falciparum
- Being tested
- Sevuparin sodium + atovaquone/proquanil, atovaquone/proquanil
- Keywords
- Uncomplicated Falciparum Malaria, Plasmodium falciparum, Antimalarial treatment, Sevuparin/DF02, Adjuvant therapy, Malanil, Peripheral blood parasitemia, Rosette formation, Maximum tolerated dose
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevuparin sodium + atovaquone/proquanilDrug
Sevuparin 4 times per day and malanil according to label
atovaquone/proquanilDrug
malanil according to label
| Study group | Role | What they receive |
|---|---|---|
| Sevuparin/DF02 | Experimental | Sevuparin/DF02 plus anti-malarial regimen (Malanil®) Receives: Drug: Sevuparin sodium + atovaquone/proquanil |
| Control | Active comparator | Anti-malarial regimen (Malanil®) alone Receives: Drug: atovaquone/proquanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities according to specified criteria
Measured: During treatment and 14 days post treatment follow-up.
Area under the curve of late stage peripheral blood parasitemia over time (Part 2).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionJan 2014
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 Malaria, FalciparumStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modus Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Anna Leitgeb, PhD, Study director, Modus Therapeutics AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442168
- Sponsor's protocol ID
- Sevuparin/DF02_TSM02
- Status last verified
- Aug 2014
- First submitted
- 23 Sep 2011
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leitgeb AM, Charunwatthana P, Rueangveerayut R, Uthaisin C, Silamut K, Chotivanich K, Sila P, Moll K, Lee SJ, Lindgren M, Holmer E, Farnert A, Kiwuwa MS, Kristensen J, Herder C, Tarning J, Wahlgren M, Dondorp AM. Inhibition of merozoite invasion and transient de-sequestration by sevuparin in humans with Plasmodium falciparum malaria. PLoS One. 2017 Dec 15;12(12):e0188754. doi: 10.1371/journal.pone.0188754. eCollection 2017.
PubMed 29244851
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study of Sevuparin/DF02, as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
- ClinicalTrials.gov ID
- NCT01442168
- Acronym / sponsor ID
- Sevuparin/DF02_TSM02
- Conditions
- Malaria, Falciparum
- Keywords
- Uncomplicated Falciparum Malaria, Plasmodium falciparum, Antimalarial treatment, Sevuparin/DF02, Adjuvant therapy, Malanil, Peripheral blood parasitemia, Rosette formation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Modus Therapeutics ABIndustry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Sep 2011 (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.
The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation.
The study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevuparin/DF02 | Experimental | Drug: Sevuparin sodium + atovaquone/proquanilSevuparin/DF02 plus anti-malarial regimen (Malanil®) |
| Control | Active comparator | Drug: atovaquone/proquanilAnti-malarial regimen (Malanil®) alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of a single species (P. falciparum)
- Counts of asexual forms of P. falciparum: 10 000- 100 000/ul with or without gametocytaemia
- Presence of fever defined as > 38°C tympanic temperature or a history of fever within the last 24 hours
Key exclusion criteria (6 listed)
- Mixed infection with other Plasmodium species
- Any criteria of severe or complicated malaria as defined by the WHO, 2010
- Use of high doses aspirin (more than 100 mg/day) or dual anti-platelet therapy or use of heparin,Low Molecular Weight Heparin (LMWH) or warfarin
- Presence of significant anemia as defined by Hb <8 g/dL or Hct < 25%
- A platelet count < 50,000/μL
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 |
|---|---|---|
| Sevuparin sodium + atovaquone/proquanilSevuparin 4 times per day and malanil according to label | Drug | Sevuparin/DF02 |
| atovaquone/proquanilmalanil according to label | Drug | Control |
Primary outcome
Dose limiting toxicities according to specified criteria
Time frame: During treatment and 14 days post treatment follow-up.
Area under the curve of late stage peripheral blood parasitemia over time (Part 2).
Time frame: 72 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Derived from this study: PubMed 29244851Leitgeb AM, Charunwatthana P, Rueangveerayut R, Uthaisin C, Silamut K, Chotivanich K, Sila P, Moll K, Lee SJ, Lindgren M, Holmer E, Farnert A, Kiwuwa MS, Kristensen J, Herder C, Tarning J, Wahlgren M, Dondorp AM. Inhibition of merozoite invasion and transient de-sequestration by sevuparin in humans with Plasmodium falciparum malaria. PLoS One. 2017 Dec 15;12(12):e0188754. doi: 10.1371/journal.pone.0188754. eCollection 2017.
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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.
Anna Leitgeb, PhD study director
Modus Therapeutics AB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sevuparin sodium + atovaquone/proquanil and atovaquone/proquanil in people with Malaria, Falciparum, run by Modus Therapeutics AB at 3 sites in Thailand.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Dose limiting toxicities according to specified criteria (time frame: During treatment and 14 days post treatment follow-up.). 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 NCT01442168, 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 19 Aug 2014.