Phase 2 Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT

NCT03172910 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PER977-02-012
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban measuring clotting times using Whole Blood Clotting Time (WBCT).

Conditions

Healthy

Keywords

PER977; Ciraparantag; Whole Blood Clotting Time (WBCT); Rivaroxaban

Outcome Measures

Primary Outcomes (2)

• Subjects Achieving Complete Reversal of Anticoagulation (WBCT is ≤ 110% of Baseline)

  Complete reversal is achieved if WBCT (manual method) is ≤ 110% of baseline at any post-baseline time point up to and including 1 hour following ciraparantag/placebo administration)

  Within 1 Hour

• Subjects Achieving Complete and Sustained Reversal of Anticoagulation (WBCT is ≤115%of Baseline)

  Complete and sustained reversal of anticoagulation is achieved for a subject if WBCT (manual method) is ≤ 115% of baseline at all time points between 1 and 8 hours (inclusive) following ciraparantag/placebo administration.

  Between 1 and 8 Hours

Study Arms (5)

Cohort 1

EXPERIMENTAL

ciraparantag (60 mg)

Drug: Ciraparantag; Drug: Rivaroxaban

Cohort 2

EXPERIMENTAL

ciraparantag (120 mg)

Drug: Ciraparantag; Drug: Rivaroxaban

Cohort 3

EXPERIMENTAL

ciraparantag (180 mg)

Drug: Ciraparantag; Drug: Rivaroxaban

Cohort 4

EXPERIMENTAL

ciraparantag (30 mg)

Drug: Ciraparantag; Drug: Rivaroxaban

Placebo

PLACEBO COMPARATOR

placebo (saline for injection)

Drug: Placebo; Drug: Rivaroxaban

Interventions

Ciraparantag DRUG

Ciraparantag (administered over 10 minutes)

Also known as: PER977, AMAG 977

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

Saline for injection

Also known as: PBO

Placebo

Rivaroxaban DRUG

Rivaroxaban 20 mg given once per day (QD) in the morning

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 50 to 75 years
• Laboratory tests (chemistry, hematology and coagulation assessments) and urinalysis performed during screening up to 36 days prior to administration of study treatment deemed not clinically significant by the principal investigator.
• No clinically significant findings on 12-lead electrocardiogram (ECG) performed during screening
• Body mass index (BMI) 18 to ≤ 32 kg/m2, inclusive
• Male subjects agree to use appropriate contraception in addition to their partner using an acceptable form of contraception, when engaging in sexual activity during the course of the study. Moreover, male subjects should not donate sperm or attempt to impregnate a partner during the course of the study and for a period of 12 weeks following discharge from the study.
• Female subjects must have a negative urine pregnancy test at screening AND: be surgically sterile OR postmenopausal for the last three months, OR in a monogamous relation with a male partner who has undergone a documented vasectomy a minimum of 6 months prior to study commencement. All females must agree to continue to use their method of birth control for the duration of the study and for a minimum of one complete menstrual cycle or 28 days following discharge from the study
• Subjects who have participated in a prior study of ciraparantag must have been discharged from the study a minimum of 1 month prior to the planned treatment.
• Subjects must understand and agree to comply with the requirements of the study and they must be willing to sign the informed consent form indicating voluntary consent to participate in the study prior to initiation of screening or study-related activities

You may not qualify if:

• History of major bleeding or clotting disorder
• Females with a history of dysfunctional uterine bleeding
• Smokers or use of tobacco and/or nicotine containing products within 3 months prior to dosing as determined by the subject's verbal history
• Pregnant or breast-feeding
• Males with a history of hormone therapy within 3 months prior to screening
• Taking any type of chronic medication (including vitamin, nutritional and herbal supplements) for more than 14 consecutive days within the 4 weeks prior to study entry (use of hormonal contraceptives is acceptable)
• Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus antibody (HCV-Ab), or Hepatitis B surface antigen (HBsAg)
• Donation of blood or blood products within 56 days prior to screening
• Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
• Active drug or alcohol dependence within the prior 12 months or any condition that, in the opinion of the Investigator, would interfere with adherence to study protocol

Sponsors & Collaborators

• Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.: lead

Study Sites (1)

Frontage Clinical Services Inc.

Secaucus, New Jersey, 07094, United States

Location

MeSH Terms

Interventions

PER977; Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Scientific Advisor
• Organization: Apollo Investment Management

rchari@kaiperheathcare.com

+352 2088 1301

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: June 1, 2017
• Study Start: May 8, 2017
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: September 2, 2025
• Results First Posted: September 2, 2025

Record last verified: 2025-08

Locations

US (1)