Phase 3 Haemophilia Trial, Recruiting NCT05145127 Sponsor: Pfizer Condition: Haemophilia
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Phase 3 Haemophilia Trial, Recruiting

NCT05145127
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You meet the minimum body weight requirement set by the related ("parent") studies.
  • You are willing and able to attend all scheduled visits, follow the treatment plan, and complete all required tests and procedures.
  • You successfully completed a related ("parent") study without being withdrawn early for any reason.

Who may not be able to join:

  • You have been treated for, or have a history of, blocked heart arteries, blood clots in veins or arteries (serious cases), or reduced blood flow to organs or tissues — unless the clot was caused by a medical catheter.
  • Your kidneys are not working well enough, based on a specific blood test result (confirm with trial site).
  • You are already planning to have surgery during the time the study would be running.
  • Your liver function is unstable, as judged by the study doctor based on your medical assessment and recent lab results.
  • You are HIV-positive and your condition has been getting worse, as judged by the study doctor based on your recent lab results and immune system levels.
  • You regularly take certain medicines that affect the immune system, such as intravenous immunoglobulin (IVIG), steroid medicines taken throughout the body, or rituximab.
  • You are currently using or planning to use treatments designed to build tolerance to, or prevent bleeding with, specific clotting factor replacement products (Factor VIII or Factor IX) during the study (confirm with trial site).
  • You are taking part in another study involving an experimental drug or vaccine, or have done so within the last 30 days (or within a specific timeframe based on the drug used), unless it is one of the related parent studies.
  • You work at the trial site, work for the company running the trial, or are a close family member of someone who does.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Pfizer CT.gov Call Center, Pfizer

Phone: 1-800-718-1021

Australian sites

Royal Children's Hospital, Melbourne, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
17 November 2021
Est. completion
31 July 2030

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇭🇷 Croatia 🇩🇰 Denmark 🇫🇷 France Hong Kong 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico Oman 🇷🇸 Serbia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of subject reporting Adverse Events; Number of subjects reporting Serious Adverse Events; Incidence and severity of thrombotic events; Incidence and severity of thrombotic microangiopathy; Number of subjects reporting Disseminated intravascular coagulalopathy/consumption coagulopathy; Incidence of clinically significant persistent NAb against marstacimab; Incidence and severity of injection site reaction; Clinically significant changes in vital signs from baseline; Incidence of clinically significant laboratory value abnormalities; Incidence of severe hypersensitivity and anaphylactic r...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov