CompletedPhase 1

Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia

United States29 participantsStarted 2011-12

Plain-language summary

This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in hemophilic animal models.

Who can participate

Age range18 Years – 64 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male subjects 18 to \<65 years old with severe hemophilia A or B with or without inhibitors to FVIII or FIX. * Subjects is willing and able to comply with the mandatory washout periods prior to screening and prior to dosing and through 48 hours post dosing. At screening this includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this includes a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72 hours through 48 hours post dosing. * Subjects must agree and commit to using a a highly effective method of birth control from the time of screening through four weeks after study drug administration. Exclusion Criteria: * Presence of a bleeding disorder in addition to hemophilia A or B. * Regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin, and routine systemic corticosteroids). * History of coronary artery disease, thrombolic disease or diagnosis of prothrombic disorder.

What they're measuring

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Timeframe: Baseline, Day 2, Day 3, and Day 15

Change From Baseline in Body Weight

Timeframe: Baseline, Day 2, Day 3, and Day 15

Change From Baseline in Body Temperature

Timeframe: Baseline, Day 2, Day 3, and Day 15

Change From Baseline in Respiration Rate

Timeframe: Baseline, Day 2, Day 3, and Day 15

Change From Baseline in Supine Pulse Rate

Timeframe: Baseline, Day 2, Day 3, and Day 15

Number of Participants With Changes Since Previous Physical Examination

Timeframe: Baseline (Day 0), Day 1, Day 2, Day 3, Day 15

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings

Timeframe: Baseline through Day 15

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs)

Trial details

NCT IDNCT01439971

SponsorCatalyst Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10

Results submitted2016-10-20

View on ClinicalTrials.gov More Hemophilia A trials

Plain-language summary

Who can participate

Age range18 Years – 64 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Timeframe: Baseline, Day 2, Day 3, and Day 15

Change From Baseline in Body Weight

Timeframe: Baseline, Day 2, Day 3, and Day 15

Change From Baseline in Body Temperature

Timeframe: Baseline, Day 2, Day 3, and Day 15

Change From Baseline in Respiration Rate

Timeframe: Baseline, Day 2, Day 3, and Day 15

Change From Baseline in Supine Pulse Rate

Timeframe: Baseline, Day 2, Day 3, and Day 15

Number of Participants With Changes Since Previous Physical Examination

Timeframe: Baseline (Day 0), Day 1, Day 2, Day 3, Day 15

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings

Timeframe: Baseline through Day 15

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs)