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Monoclonal Antibodies

NXT007 Dose Escalation for Hemophilia A

Phase 1 & 2

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until study completion or discontinuation (up to 7.5 years)

Awards & highlights

Study Summary

This trial is looking at the safety and effectiveness of giving multiple doses of NXT007 to men and boys with severe or moderate hemophilia A. The study will include participants from around the world and will investigate

Who is the study for?

This trial is for males with severe or moderate Hemophilia A, weighing over 40 kg. They must have a history of bleeding episodes and be willing to follow the study's procedures. Participants can't join if they have poor kidney, liver, or blood function.Check my eligibility

What is being tested?

The trial tests NXT007 in adults and teens with Hemophilia A to see how safe it is and how well it works at different doses. It's an early-stage (Phase I/II) global study where everyone gets the drug; there's no comparison group.See study design

What are the potential side effects?

Since this is an early-phase trial for NXT007, specific side effects are being studied but may include reactions related to immune response, infusion site reactions, and potential impacts on liver or kidney functions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until study completion or discontinuation (up to 7.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until study completion or discontinuation (up to 7.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until study completion or discontinuation (up to 7.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Grading Scale

Number of Participants with at Least One Abnormality on Electrocardiogram (ECG) Recordings

Number of Participants with at Least One Clinical Laboratory Test Abnormality for Blood Chemistry Parameters

+2 more

Secondary outcome measures

Area Under the Plasma Concentration-Time Curve (AUC) of NXT007 After the First Dose

Maximum Observed Plasma Concentration (Cmax) of NXT007 After the First Dose

Mean Calculated Annualized Bleeding Rate for All Bleeds

+15 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: NXT007 Dose EscalationExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,090,093 Total Patients Enrolled

13 Trials studying Hemophilia A

1,336 Patients Enrolled for Hemophilia A

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,810 Total Patients Enrolled

14 Trials studying Hemophilia A

1,303 Patients Enrolled for Hemophilia A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to take part in this research study?

"Individuals aged between 12 and 59 years diagnosed with hemophilia A are eligible for participation in this trial, which aims to enroll approximately 40 participants."

Answered by AI

Are there several sites conducting this trial in North America?

"Currently, this clinical study is enrolling participants at 9 sites. Among them are Hamilton, Indianapolis, and Warsaw. Opting for a nearby clinic can reduce the need for extensive travel if you decide to participate in the trial."

Answered by AI

Can individuals aged 60 and above participate in this research study?

"Potential participants must be between 12 and 59 years old to meet the eligibility criteria. There are a total of 50 research investigations dedicated to individuals under 18, and an additional 77 studies focusing on those above the age of 65."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"As per clinicaltrials.gov, this medical investigation is presently in need of volunteers. The trial was initially listed on September 21st, 2023 and last modified on March 8th, 2024."

Answered by AI

What is the overall count of individuals involved in this clinical research?

"This research trial requires the enrollment of 40 individuals who meet the defined eligibility criteria. Potential participants can join this study at various locations, including Hamilton Health Sciences Corporation in Hamilton, Indiana and Indiana Hemophilia & Thrombosis Center in Indianapolis, Lombardia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

2023. "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05987449.

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