CCT-102 or Expectant Management in Delayed Pregnancy Loss

Phase 3

Active, not recruiting

• Conditions: Early Pregnancy Loss, Delayed Pregnancy Loss
• Interventions: Combination Product: CCT-102 A and CCT-102 B

• Registration Number: NCT06121063
• Lead Sponsor: Conceptra Biosciences, LLC

Brief Summary

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

Detailed Description

This is a Phase 3, open-label, multi-center study to assess the efficacy of a CCT-102 regimen 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 choose between the 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 Timeline

• Study Start: 2023-07-21
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-07
• Status Verified: 2025-05
• Primary Completion: 2025-05-15
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 183

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:

   1. Embryonic demise: no embryonic cardiac activity when embryo measures 7 mm or greater; OR,
   2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCT-102 Regimen	CCT-102 A and CCT-102 B	CCT-102 A/B regimen

Primary Outcome Measures

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

Trial Locations

Locations (15)

Noble Clinical Research; 🇺🇸 Tucson, Arizona, United States

Amicis Research Center, LLC; 🇺🇸 San Fernando, California, United States

Emerald Coast Obstetrics and Gynecology; 🇺🇸 Panama City, Florida, United States

Cypress Medical Research Center; 🇺🇸 Wichita, Kansas, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Las Vegas Clinical Trials; 🇺🇸 Las Vegas, Nevada, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Eastern Carolina Women's Center, PA; 🇺🇸 New Bern, North Carolina, United States

Lyndhurst Clin Research; 🇺🇸 Winston-Salem, North Carolina, United States

Penn State Hershey Obstetrics and Gynecology; 🇺🇸 Hershey, Pennsylvania, United States

Maximos Obstetrics & Gynecology; 🇺🇸 League City, Texas, United States

Prime Clinical Research - Lewisville North Valley; 🇺🇸 Lewisville, Texas, United States

Tidewater Clinical Research; 🇺🇸 Virginia Beach, Virginia, United States

The University of Texas Medical Branch at Galveston; 🇺🇸 Galveston, Texas, United States