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).
Brief Title
CCT-102 or Expectant Management in Delayed Pregnancy Loss
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Early Pregnancy Loss, Delayed Pregnancy Loss
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
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
Inclusion 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.
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.
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
50 Years
Minimum Age
18 Years
NCT Id
NCT06121063
Org Class
Industry
Org Full Name
Conceptra Biosciences, LLC
Org Study Id
PRT-CO-CCT-102.001
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Efficacy and Safety of a CCT-102 Regimen or Expectant Management in the Treatment of First Trimester Pregnancy Loss
Primary Outcomes
Outcome Description
Evacuation of delayed pregnancy loss within 7 days (up to and including Day 7), confirmed by ultrasound.
Outcome Measure
Resolution of pregnancy loss
Outcome Time Frame
7 Days
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
50
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Melissa Wong
Investigator Email
mewong@montefiore.org