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Clinical study for effectiveness of rituximab for acquired coagulopathy

Clinical study for effectiveness of rituximab for acquired coagulopathy - Rituximab Trial for acquired coagulopathy

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024612
Enrollment
10
Registered
2016-11-01
Start date
2016-11-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

acquired coagulopathy

Interventions

Rituximab

Sponsors

Gunma University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients who had a diagnosis of a hemorrhagic acquired coagulation disorder Age at agreement acquisition is the patients 85 years or younger 20 years old or older. About participation in this study, a document agreement is the obtained patients from person . (4) The patients who meet criteria of the following rituximab administration. (1) Recurrence, the intractable case that is refractory to steroid therapy (2) The patients that attending physitian judged that steroid use was not suitable for some reason by initial treatment. The steroid unsuitable corresponds to following a) The patients that exacerbation is expected with mental cognitive impairment. b) The patients who had the diabetes mellitus inadequate control. c) The patients who have hemorrhagic gastric ulcer. d) In addition, the patients that attending physitian judged steroid use to be inadequate.

Exclusion criteria

Exclusion criteria: (1) The men that an agreement is not obtained in preventing conception during study drug dosing period. (2) The women who may be pregnant during nursing during pregnancy and the women who hope for pregnancy during study drug dosing period. (3) The patients who are proved to have an HIV antibody. (4) The patients that positive was confirmed in one or more with HBs antigen, HBs antibody, anti-hepatitis B core antigen and HCV antibody. (however, we do not do it with the subject of the exclusion by this rule when a thing with the vaccination is clear when an examination of hepatitis B is positive) (5) In addition, the patients whom doctor attending judged to be inadequate as an object of this study.

Design outcomes

Primary

MeasureTime frame
Disappearance of coagulation factor inhibitor on day 56 after rituximab administration

Countries

Japan

Contacts

Public ContactOgawa, Yoshiyuki

Gunma Unviersity School of Medicine

yo-ogawa@gunma-u.ac.jp027-220-8166

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026