CCT-102 vs. Expectant Management in Delayed Pregnancy Loss

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Efficacy and Safety of a CCT-102 Regimen Versus Expectant Management in the Treatment of First Trimester Pregnancy Loss

Conditions
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Delayed Pregnancy Loss, Early Pregnancy Loss

Intervention / Treatment
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* Combination Product: CCT-102 A and CCT-102 B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 50 Ability to provide informed consent Hemodynamically stable Closed cervical os If fetus exists, clinical observation indicates gestation is no more than 10 weeks Diagnosis of delayed pregnancy loss, confirmed by ultrasound, based on: Embryonic demise: no embryonic cardiac activity when embryo measures 7 mm or greater; OR, 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 Diagnosis of an incomplete or inevitable abortion including more than slight bleeding at enrollment and/or open os within the prior week. Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass Hemoglobin <10 g/dL Coagulation disorder, inherited porphyrias, and/or current anticoagulants use Chronic adrenal failure Concurrent chronic corticosteroid therapy History of trophoblastic disease Current presence of an IUD History of allergy or contraindications to the use to mifepristone, misoprostol, or other prostaglandins Any condition that, in the opinion of the investigator, makes the patient unsuitable for study entry Any other current medical condition that jeopardizes the patient's ability to safely participate in the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open, label, multi-center, randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CCT-102 Regimen<br>CCT-102 A/B regimen | Combination Product: CCT-102 A and CCT-102 B<br>* 2 day oral regimen<br>|
| No Intervention: Expectant management<br>Non-treatment, 'waitful watching' | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of pregnancy loss | Evacuation of delayed pregnancy loss within 7 days (up to and including Day 7), confirmed by ultrasound. | 7 Days |