CCT-102 or Expectant Management in Delayed Pregnancy Loss

Last updated: February 11, 2025
Sponsor: Conceptra Biosciences, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

CCT-102 A and CCT-102 B

Clinical Study ID

NCT06121063
PRT-CO-CCT-102.001
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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 orgreater; OR,

  8. Anembryonic pregnancy: mean gestational sac diameter of 25 mm or greater, withno detectable embryo.

Exclusion

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 slightbleeding 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, orother prostaglandins

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

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

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: CCT-102 A and CCT-102 B
Phase: 3
Study Start date:
July 21, 2023
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Physicians Research Group

    Tempe, Arizona 85284
    United States

    Site Not Available

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • A&B Clinical Research, Inc.

    San Diego, California 92103
    United States

    Site Not Available

  • Amicis Research Center, LLC

    San Fernando, California 91340
    United States

    Active - Recruiting

  • Emerald Coast Obstetrics and Gynecology

    Panama City, Florida 32405
    United States

    Active - Recruiting

  • The IVF Center

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Clinical Research Prime

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Cypress Medical Research Center

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Gulfport, Mississippi 39503
    United States

    Site Not Available

  • Velocity Clinical Research, Gulfport

    Gulfport, Mississippi 39503
    United States

    Active - Recruiting

  • Velocity Clinical Research Hastings

    Hastings, Nebraska 68901
    United States

    Site Not Available

  • Velocity Clinical Research, Hastings

    Hastings, Nebraska 68901
    United States

    Active - Recruiting

  • Las Vegas Clinical Trials

    Las Vegas, Nevada 89030
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Eastern Carolina Women's Center, PA

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • Lyndhurst Clin Research

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Penn State Hershey Obstetrics and Gynecology

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • MUSC Women's Health

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • The University of Texas Medical Branch at Galveston

    Galveston, Texas 77555
    United States

    Active - Recruiting

  • Maximos Obstetrics & Gynecology

    League City, Texas 77573
    United States

    Active - Recruiting

  • Prime Clinical Research - Lewisville North Valley

    Lewisville, Texas 75067
    United States

    Active - Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Tidewater Clinical Research

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Tidewater Clinical Research

    Virginia Beach, Virginia 23456
    United States

    Active - Recruiting

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