A multicentre, prospective, single arm study of bortezomib combined with glucocorticoid in the salvage treatment of relapsed / refractory acquired hemophilia A (AHA)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035067

Enrollment

Unknown

Registered

2020-07-30

Start date

2020-05-11

Completion date

Unknown

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed / refractory acquired hemophilia A (AHA)

Interventions

Case series:bortezomib combined with glucocorticoid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as AHA; 2. Patients who don't reach CR after an observation time of 1 month after initial treatment with rituximab, CTX and glucocorticoid in the past (the observation time includes taper of glucocorticoid); patients with FVIII: C dropping below 50% again after reaching the initial CR by treatment with rituximab, CTX and glucocorticoid; patients who have been treated with rituximab, CTX and glucocorticoid for less than 1 month, but the FVIII inhibitor don't decrease at all; 3. Both men and women can be enrolled; 4. Postmenopausal women or women of childbearing age who have strict contraception; 5. Patients with good compliance.

Exclusion criteria

Exclusion criteria: 1. Congenital hemophilia with inhibitors; 2. Pregnant and breastfeeding women; 3. Serum transaminase and bilirubin greater than 1.5 times the upper limit of normal value; 4. Hepatitis B surface antigen or hepatitis C antibody or HIV antibody (I + II) or syphilis antibody positive; 5. Patients with poor compliance; 6. Those who cannot take contraceptive measures during the clinical trial; 7. Patient who is considered by the investigator not suitable for clinical study.

Design outcomes

Primary

Measure	Time frame
The overall response rate at the 12th week of treatment period;The CR rate at the 12th week of treatment period;The PR rate at the 12th week of treatment period;	—

Secondary

Measure	Time frame
The time for patients to reach CR;The time for patients to reach PR;The proportion of patients who continue to be CR in the 36th week of observation period after reaching CR at treatment poeriod;The proportion of patients whose FVIII inhibitor titer increases to > 0.6BU/mL within 36 weeks of follow up period after reaching CR in the treatment period;The proportion of patients whose FVIII:C decreases below 50% within 36 weeks of follow up period after reaching PR in the treatment period;	—

Measure

Time frame

The time for patients to reach CR;The time for patients to reach PR;The proportion of patients who continue to be CR in the 36th week of observation period after reaching CR at treatment poeriod;The proportion of patients whose FVIII inhibitor titer increases to > 0.6BU/mL within 36 weeks of follow up period after reaching CR in the treatment period;The proportion of patients whose FVIII:C decreases below 50% within 36 weeks of follow up period after reaching PR in the treatment period;

—

Countries

China

Contacts

Public ContactLei Zhang

Institute of Hematology& Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

zhanglei1@ihcams.ac.cn+86 13502118379

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026