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| Sponsor: | Daval International Limited |
|---|---|
| Information provided by: | Daval International Limited |
| ClinicalTrials.gov Identifier: | NCT00769028 |
Purpose
To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation. The secondary objective of the study is to assess the efficacy of AIMSPRO as a therapeutic agent for SSc using inter alia the SSc-HAQ questionnaire and the modified Rodnan skin score.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Sclerosis |
Drug: Hyperimmune caprine serum Drug: Albumin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind Placebo-Controlled Pilot Study of Safety and Tolerability of AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| AIMSPRO: Experimental |
Drug: Hyperimmune caprine serum
Subcutaneous injection of serum, 1ml twice weekly for 6 months
|
| Placebo: Placebo Comparator |
Drug: Albumin
Subcutaneous injection of albumin, 1ml twice weekly for 6 months
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hemoglobin > 8.5 g/dL WBC > 3.5 x 10^9/L Neutrophils > 1.5 x 10^9/L Platelets > 100 x 10^9/L SGOT (AST) and alkaline phosphatase levels must be within twice the upper limit of normal range for the laboratory conducting the test.
Exclusion Criteria:
Contacts and Locations| Contact: Christopher P Denton, PhD FRCP | +442077940432 | cdenton@medsch.ucl.ac.uk |
| United Kingdom | |
| Centre for Rheumatology and Connective Tissue Diseases, Lower Ground Floor, Royal Free Hospital NHS Trust, Hampstead | Recruiting |
| London, United Kingdom, NW3 2QG | |
| Principal Investigator: Christopher P Denton, PhD FRCP | |
| Sub-Investigator: Niamh P Quillinan, MB MRCPI | |
| Sub-Investigator: Rachel Ochiel | |
| Sub-Investigator: Sandra Zimba | |
| Principal Investigator: | Christopher P Denton, PhD FRCP | Royal Free Hospital NHS Trust |
More Information
| Responsible Party: | Royal Free Hospital NHS Trust ( Prof. Christopher Denton ) |
| Study ID Numbers: | DISS01 |
| Study First Received: | October 7, 2008 |
| Last Updated: | May 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00769028 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Systemic sclerosis Diffuse cutaneous systemic sclerosis Scleroderma |
Biological Hyperimmune caprine serum Goat Serum |
|
Pathologic Processes Skin Diseases Connective Tissue Diseases |
Scleroderma, Diffuse Sclerosis Scleroderma, Systemic |