Clinical trial NCT06121063: CCT-102 or Expectant Management in Delayed Pregnancy Loss
Official title: The Efficacy and Safety of a CCT-102 Regimen or Expectant Management in the Treatment of First Trimester Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Early Pregnancy Loss, Delayed Pregnancy Loss
Lead sponsor: Conceptra Biosciences, LLC
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, label, multi-center, randomized study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of pregnancy loss
timeFrame: 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: San Fernando
country: United States
facility: Amicis Research Center, LLC
state: California
city: Panama City
country: United States
facility: Emerald Coast Obstetrics and Gynecology
state: Florida
city: Wichita
country: United States
facility: Cypress Medical Research Center
state: Kansas
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New Bern
country: United States
facility: Eastern Carolina Women's Center, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clin Research
state: North Carolina
city: Hershey
country: United States
facility: Penn State Hershey Obstetrics and Gynecology
state: Pennsylvania
city: Galveston
country: United States
facility: The University of Texas Medical Branch at Galveston
state: Texas
city: League City
country: United States
facility: Maximos Obstetrics & Gynecology
state: Texas
city: Lewisville
country: United States
facility: Prime Clinical Research - Lewisville North Valley
state: Texas
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research
state: Virginia
Study officials:
References: