MERMAID: CCT-102 vs. Expectant Management in Delayed Pregnancy Loss

• Sponsor: Conceptra Biosciences, LLC (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06121063
• Collaborator: (none)
• Enrollment: 160
• Arms: 2
• Anticipated Duration (Months): 7

Study Details

Study Description

Brief Summary

A Phase 3, multi-center clinical trial of a CCT-102 regimen compared to expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL).

Condition or Disease	Intervention/Treatment	Phase
Delayed Pregnancy Loss, Early Pregnancy Loss	Combination Product: CCT-102 A and CCT-102 B	Phase 3

Detailed Description

This is a Phase 3, open-label, multi-center study to assess the efficacy of a CCT-102 regimen compared to expectant management for uterine evacuation in first trimester delayed pregnancy loss (DPL). Eligible study participants will have ultrasound documented DPL with estimated gestational age 10 weeks or less.

DPL is defined as arrest of embryonic or fetal development, in first trimester, where the cervix is closed and there is no or only slight bleeding. This includes: 1) anembryonic pregnancy, and 2) embryonic demise. Expectant management, which is an accepted treatment protocol recognized in 2018 ACOG Practice Bulletin on Early Pregnancy Loss (ACOG, 2018), consists of patient monitoring with no additional treatment.

Eligible participants will be randomized 1:1 to investigational product or expectant management on Day 1. They will be evaluated for the primary endpoint (resolution of DPL) on Study Day 7. All participants will be followed to Day 28.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Open, label, multi-center, randomized studyOpen, label, multi-center, randomized study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy and Safety of a CCT-102 Regimen Versus Expectant Management in the Treatment of First Trimester Pregnancy Loss
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CCT-102 Regimen CCT-102 A/B regimen	Combination Product: CCT-102 A and CCT-102 B; 2 day oral regimen
No Intervention: Expectant management Non-treatment, 'waitful watching'

Outcome Measures

Primary Outcome Measures

1. Resolution of pregnancy loss [7 Days]

   Evacuation of delayed pregnancy loss within 7 days (up to and including Day 7), confirmed by ultrasound.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age 18 to 50

2. Ability to provide informed consent

3. Hemodynamically stable

4. Closed cervical os

5. If fetus exists, clinical observation indicates gestation is no more than 10 weeks

6. Diagnosis of delayed pregnancy loss, confirmed by ultrasound, based on:

7. Embryonic demise: no embryonic cardiac activity when embryo measures 7 mm or greater; OR,

8. Anembryonic pregnancy: mean gestational sac diameter of 25 mm or greater, with no detectable embryo.

Exclusion Criteria:

1. Unwillingness or inability to comply with the study protocol and visit schedule

2. Diagnosis of an incomplete or inevitable abortion including more than slight bleeding at enrollment and/or open os within the prior week.

3. Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass

4. Hemoglobin <10 g/dL

5. Coagulation disorder, inherited porphyrias, and/or current anticoagulants use

6. Chronic adrenal failure

7. Concurrent chronic corticosteroid therapy

8. History of trophoblastic disease

9. Current presence of an IUD

10. History of allergy or contraindications to the use to mifepristone, misoprostol, or other prostaglandins

11. Any condition that, in the opinion of the investigator, makes the patient unsuitable for study entry

12. Any other current medical condition that jeopardizes the patient's ability to safely participate in the trial

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Conceptra Biosciences, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Conceptra Biosciences, LLC
• ClinicalTrials.gov Identifier: NCT06121063
• Other Study ID Numbers: PRT-CO-CCT-102.001
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Abortion, Spontaneous; Fetal Death

Study Results

No Results Posted as of Nov 7, 2023