CCT-102 or Expectant Management in Delayed Pregnancy Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-21

Study Completion Date

2025-07-30

Brief Summary

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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).

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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 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.

Conditions

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Early Pregnancy Loss, Delayed Pregnancy Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open, label, multi-center, randomized study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CCT-102 Regimen

CCT-102 A/B regimen

Group Type ACTIVE_COMPARATOR

CCT-102 A and CCT-102 B

Intervention Type COMBINATION_PRODUCT

2 day oral regimen

Expectant management

Non-treatment, 'waitful watching'

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CCT-102 A and CCT-102 B

2 day oral regimen

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes