CCT-102 vs. Expectant Management in Delayed Pregnancy Loss
Purpose
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
- Early Pregnancy Loss, Delayed Pregnancy Loss
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Open, label, multi-center, randomized study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator CCT-102 Regimen |
CCT-102 A/B regimen |
|
|
No Intervention Expectant management |
Non-treatment, 'waitful watching' |
|
Recruiting Locations
Galveston, Texas 77555
Jerome Yaklic
More Details
- Status
- Recruiting
- Sponsor
- Conceptra Biosciences, LLC
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.