Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia
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ClinicalTrials.gov Identifier: NCT01530555 |
Recruitment Status :
Completed
First Posted : February 10, 2012
Last Update Posted : February 25, 2016
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Condition or disease | Intervention/treatment | Phase |
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Acquired Aplastic Anaemia | Drug: Rabbit ATG, Thymoglobuline (Genzyme) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment arm
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Drug: Rabbit ATG, Thymoglobuline (Genzyme)
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- Response [ Time Frame: 2 years ]Primary outcome is response at 6 months post ATG treatment
- Over all survival [ Time Frame: 2 years ]Secondary outcome variables include overall survival and failure free survival at 2 years post ATG treatment

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Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- To define aplastic anaemia there must be at least two of the following: (1) haemoglobin < 10g/dl; (2) platelet count < 50 x 109/l; (3) neutrophil count < 1.5 x 109/l, and a hypocellular bone marrow on bone marrow biopsy
- Time from diagnosis to study registration ≤ 6mths
- No prior treatment except for haemopoietic growth factors given for no more than 4 weeks, and androgens.
- Age ≥ 16yrs (≥ 18yrs in Germany in accordance with German law), with no upper age limit.
Exclusion criteria:
- Eligibility for an HLA-matched sibling donor transplant for SAA patients
- Prior therapy with ATG or CSA
- Haematopoeitic growth factors more than 4 weeks before study enrollment
- Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome
- Evidence of myelodysplastic disease
- Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of PNH associated thrombosis or a PNH clone > 50% by flow cytometry
- Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
- Subject is pregnant (e.g. positive HCG test) or is breast feeding
- Severe uncontrolled infection or unexplained fever > 38oC
- Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530555
Principal Investigator: | Ahmed Al Zahrani, MD | King Faisal Specialist Hospital & Research Center |
Responsible Party: | King Faisal Specialist Hospital & Research Center |
ClinicalTrials.gov Identifier: | NCT01530555 |
Other Study ID Numbers: |
2081-005 |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | February 25, 2016 |
Last Verified: | February 2012 |
Anemia Anemia, Aplastic Hematologic Diseases Bone Marrow Diseases |
Thymoglobulin Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents |