Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2009/091/000860
CTRI/2009/091/000860
Completed
Phase 3

A multi-center, prospective, open-label, clinical trial to assess the safety and the efficacy of a new intravenous immune globulin (IGIV3I Grifols 10%) in patients with idiopathic (immune) thrombocytopenic purpura. - Nil

Spectrum Clinical Research Pvt Ltd0 sites75 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: null- Chronic idiopathic (immune) thrombocytopenic purpuraHealth Condition 2: D693- Immune thrombocytopenic purpuraHealth Condition 3: D693- Immune thrombocytopenic purpura

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- Chronic idiopathic (immune) thrombocytopenic purpuraHealth Condition 2: D693- Immune thrombocytopenic purpuraHealth Condition 3: D693- Immune thrombocytopenic purpura
Sponsor
Spectrum Clinical Research Pvt Ltd
Enrollment
75
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Spectrum Clinical Research Pvt Ltd

Eligibility Criteria

Inclusion Criteria

  • •1\.To be male or female.
  • •2\.To be 18 to 70 years of age.
  • •3\.To have a diagnosis of chronic ITP.
  • •4\.To have a platelet count ≤ 20 x 10\.e9/L.
  • •5\.To sign an informed consent form.

Exclusion Criteria

  • •1\.Has a history or clinical evidence of medical conditions (other than ITP) felt to be the underlying cause of the thrombocytopenia.
  • •2\.Has a diagnosis of secondary immune thrombocytopenia.
  • •3\.Has a history of severe (e.g. anaphylactic) reactions to blood or any blood\-derived product.
  • •4\.Is suffering a serious and/or life\-threatening hemorrhage/bleeding defined as:
  • •\-Any intracranial or central nervous system bleeding.
  • •\-Any hemorrhagic event in which the subject is at risk of death at the time of the event.
  • •5\.Is known to have IgA deficiency.
  • •6\.Has a documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past.
  • •7\.Is anemic (Hgb 9 g/dL).
  • •8\.Is known to have a positive test for either HIV 1/2 or HCV

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
A clinical trial to test the safety and effectiveness of Neuralzhein in management of memory loss related to age.Health Condition 1: F54- Psychological and behavioral factors associated with disorders or diseases classified elsewhere
CTRI/2019/08/020711exxus Laboratories DBA OPUS PHARMA
Completed
Phase 2
Clinical study on JPF-16 Capsules in Sexual Dysfunction in FemalesHealth Condition 1: null- Female Sexual Dysfunction
CTRI/2017/06/008791Chatarubhuj Pharmaceutical Co30
Recruiting
Phase 1
A clinical study to assess how safe and effective it is for subjects with hepatocellular carcinoma (HCC) to receive radiation therapy with TheraSphere followed by immunotherapy (durvalumab and tremelimumab treatment)Hepatocellular CarcinomaMedDRA version: 21.1Level: LLTClassification code: 10049010Term: Carcinoma hepatocellular Class: 10029104Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
CTIS2023-508945-41-00Biocompatibles UK Limited107
Completed
Phase 3
To evaluate safety and performance of CREDENCEâ?¢ BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subjects with Critical Limb Ischemiafollowing Percutaneous Transluminal Angioplasty of below the knee arteries.Health Condition 1: I739- Peripheral vascular disease, unspecified
CTRI/2016/11/007473Meril Life Sciences Pvt Ltd30
Completed
Phase 2
Clinical study on Ayuvita Forte Capsule in irregular periods with cysts in ovary.
CTRI/2019/11/022183Welex Laboratories Pvt Ltd25