NCT06875141

Brief 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 (PACTR202404895013782), in accordance with ICMJE and WHO requirements. This listing serves as the primary and authoritative registration record for this investigator-initiated study.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2025

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

Same day

First QC Date

March 4, 2025

Last Update Submit

May 30, 2025

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment adverse events

    Until 6 weeks after the due date

Study Arms (1)

Part 1

EXPERIMENTAL

Part 1

Biological: DM199

Interventions

DM199BIOLOGICAL

DM199 is a synthetic form of rhKLK1

Part 1

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please refer to the Pan African Clinical Trials Registry (PACTR202404895013782).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

DM199

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 13, 2025

Study Start

May 1, 2025

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share