Pre-EclampsiaNCT06875141
DM199 for Pregnancy Complications
A study testing DM199 in people with Pre-Eclampsia, run by DiaMedica Therapeutics Inc.
Trial summary
This entry was submitted in error by DiaMedica Therapeutics, Inc. and was not authorized by any of the trial Investigators or study sponsor (Stellenbosch University). The clinical trial, DM199 for Pregnancy Complications, was prospectively registered with the Pan African Clinical Trials Registry… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- DM199
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2025to May 2025
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Please refer to the Pan African Clinical Trials Registry (PACTR202404895013782).
About this study
This entry was submitted in error by DiaMedica Therapeutics, Inc. and was not authorized by any of the trial Investigators or study sponsor (Stellenbosch University).
The clinical trial, DM199 for Pregnancy Complications, was prospectively registered with the Pan African Clinical Trials Registry (PACTR202404895013782), in accordance with ICMJE and WHO requirements. This listing serves as the primary and authoritative registration record for this investigator-initiated study.
- Conditions
- Pre-Eclampsia
- Being tested
- DM199
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM199Biological
DM199 is a synthetic form of rhKLK1
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Part 1 Receives: Biological: DM199 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment adverse events
Measured: Until 6 weeks after the due date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Why it stopped: This entry was unauthorized and has been withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiaMedica Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875141
- Sponsor's protocol ID
- PACTR202404895013782
- Status last verified
- May 2025
- First submitted
- 4 Mar 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DM199 for Pregnancy Complications
- ClinicalTrials.gov ID
- NCT06875141
- Acronym / sponsor ID
- PACTR202404895013782
- Conditions
- Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This entry was unauthorized and has been withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DiaMedica Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- 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.
This entry was submitted in error by DiaMedica Therapeutics, Inc. and was not authorized by any of the trial Investigators or study sponsor (Stellenbosch University).
The clinical trial, DM199 for Pregnancy Complications, was prospectively registered with the Pan African Clinical Trials Registry (PACTR202404895013782), in accordance with ICMJE and WHO requirements. This listing serves as the primary and authoritative registration record for this investigator-initiated study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Biological: DM199Part 1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| DM199DM199 is a synthetic form of rhKLK1 | Biological | Part 1 |
Primary outcome
Incidence of treatment adverse events
Time frame: Until 6 weeks after the due date
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DM199 in people with Pre-Eclampsia, run by DiaMedica Therapeutics Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of treatment adverse events (time frame: Until 6 weeks after the due date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.