A placebo controlled study of efficacy and safety in pregnant women with a history of unexplained recurrent pregnancy loss.

Phase 1

• Conditions: nexplained recurrent pregnancy loss. A distinct disorder from sporadic pregnancy loss and is characterized by the loss of multiple pregnancies; MedDRA version: 17.0Level: LLTClassification code 10072314Term: Pregnancy lossSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-000084-40-GB
• Lead Sponsor: ora Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-31
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Pre-menopausal female 18-37 years of age at consent, trying to conceive
2.Documented history of unexplained recurrent pregnancy loss, defined as:
a. Spontaneous loss of three or more pregnancies prior to 20 completed weeks of gestation
b.At least two of the losses must have involved intrauterine clinical pregnancies prior to
20 completed weeks of gestation with normal or unknown fetal karyotype
3.Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
4.Body mass index (BMI) of 19-35 kg/m2 at consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Greater than 5 weeks of gestation (i.e. greater than 3 weeks since the ovulation date) when presenting for randomization. Ovulation date is defined as the day after the ovulation test is first positive.
2.Known karyotype abnormalities in either the participant or her current male partner
3.Uncorrected clinically significant intrauterine abnormalities present at the time of consent (as assessed by ultrasound, hysterosonography, hysterosalpingography, or hysteroscopy within 3 years prior to consent)
4.Abnormal vaginal bleeding of unknown cause
5.Current diagnosis of infertility in either the participant or her current male partner
6.Current or past diagnosis of the following:
a. Systemic autoimmune disease (e.g. systemic lupus erythematosus, Hashimoto’s thyroiditis, Graves’ disease, rheumatoid arthritis)
b. Antiphospholipid syndrome or disorder presence of lupus anticoagulant or anti-cardiolipin antibodies
c.Protein C or S deficiency
d. Other thrombophilia or evidence of thrombophilia (e.g. recurrent deep vein thrombosis, pulmonary embolism)
e.Hyperprolactinemia
f. High risk of cervical incompetence in the investigator’s opinion
g.High-grade cervical dysplasia with conization/surgery
7.Any uncontrolled clinically significant medical condition (e.g. asthma, type II diabetes, infection)
8.The following laboratory abnormalities at initial consent and within 3 months prior to randomization
a.Thrombocytopenia or thrombocytosis (platelet count < 75,000/µL or > 500,000/µL)
b.Neutropenia or neutrophilia (absolute neutrophil count < 1500/µL or > 10,000/µL)
c.Leukopenia or leukocytosis (white blood cell count < 3000/µL or > 15,000/µL)
d.Creatinine, hepatic transaminases, lactate dehydrogenase (LDH), alkaline phosphatase, or uric acid = 1.5x upper limit of normal (ULN)
9.Use of lithium within 1 month prior to consent
10.Known hypersensitivity to any rhG-CSF drug product, any of its components, or any E. coli-derived proteins
11.History of any of the following conditions:
a.Human immunodeficiency virus (HIV) infection
b.Malignancy within the past 5 years other than treated basal cell carcinoma or squamous cell carcinoma of the skin
c.Splenomegaly or splenic rupture
d.Adult respiratory distress syndrome (ARDS), acute lung injury (ALI), or pulmonary edema
e.Sickle cell anemia
f.Acute myocardial infarction, stroke, or revascularization (coronary or cerebral)
12.Previous rhG-CSF therapy for any indication
13.In the investigator’s opinion, any contraindication to the use of an investigational drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified