NCT07791836

Brief Summary

This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Aug 2026Feb 2027

First Submitted

Initial submission to the registry

June 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Last Updated

August 28, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 29, 2026

Last Update Submit

August 27, 2026

Conditions

Hemophilia AHemophilia

Keywords

Factor VIIICoageightPrevalenceImmunogenicityRecombinant Factor VIII with Fc FusionHemophilia A

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.)

    Assessing the prevalence of inhibitors against factor VIII in the study population, as measured by a positive Bethesda test

    Day 0 (-7 to 0 days)

Study Arms (1)

Patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.)

Drug: efmoroctocog alfa

Interventions

efmoroctocog alfaDRUG

This study assesses patients with a history of at least 10 exposure days (EDs) to recombinant factor VIII with Fc fusion (Coageight) within the 12 months prior to enrollment.

Also known as: Recombinant Factor VIII with Fc Fusion, Coageight
Patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.)

Eligibility Criteria

Age2 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male candidates are eligible to participate.
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 262 Iranian patients diagnosed with hemophilia A and treated with Coageight® (rFVIII-Fc fused, AryoGen Pharmed Co.)

You may qualify if:

  • Male patients aged 2 years or older with a signed informed consent by them or their legal guardian
  • Hemophilia A patients with ≥ 50 exposure days to any FVIII product, based on the patient's medical record and the physician's opinion
  • History of receiving at least 10 exposure days with Coageight during the past 12 months, based on the patient's medical records and the physician's opinion

You may not qualify if:

  • History of any other coagulation disorders except hemophilia A and disorders related to immune system deficiencies (except for the patients who have undergone Immune Tolerance Induction (ITI) treatment due to inhibitor formation)
  • Patients with hepatitis B or C (based on the patient's medical records), due to potential interference with the inhibitor assessments
  • Participation or intent to participate in another research study during this study period
  • Inability or unwillingness of the patient to meet the protocol requirements, as determined by the physician (e.g., physical or psychological issues)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Shahid Baqaei 2 Hospital

Ahvāz, Ahvaz, 6138933333, Iran

Location

Seyyed al-Shohada Hospital

Isfahan, Isfahan, 8184917354, Iran

Location

Soroor Clinic

Mashhad, Mashhad, 9139963185, Iran

Location

Shahid Ayatollah Dastgheib Hospital

Shiraz, Shiraz, 7145683769, Iran

Location

Imam Khomeini Hospital

Tehran, Tehran Province, 1419733141, Iran

Location

Mofid Children's Hospital

Tehran, Tehran Province, 1551415468, Iran

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

factor VIII-Fc fusion proteinFactor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Central Study Contacts

Hamidreza Kafi, Clinical Pharmecy Ph.D

CONTACT

00982143473000Kafi.H@Orchidpharmed.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2026

First Posted

August 28, 2026

Study Start

August 23, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2027

Last Updated

August 28, 2026

Record last verified: 2026-06

Locations

IR(6)