|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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: | September 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AIMSPRO |
Drug: Hyperimmune caprine serum
Subcutaneous injection of serum, 1ml twice weekly for 6 months
Other Names:
|
| Placebo Comparator: Placebo |
Drug: Albumin
Subcutaneous injection of albumin, 1ml twice weekly for 6 months
Other Name: Placebo
|
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| United Kingdom | |
| Centre for Rheumatology and Connective Tissue Diseases, Lower Ground Floor, Royal Free Hospital NHS Trust, Hampstead | |
| London, United Kingdom, NW3 2QG | |
| Principal Investigator: | Christopher P Denton, PhD FRCP | Royal Free Hospital NHS Trust |
More Information
| Responsible Party: | Prof. Christopher Denton, Royal Free Hospital NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00769028 History of Changes |
| Other Study ID Numbers: | DISS01 |
| Study First Received: | October 7, 2008 |
| Last Updated: | August 16, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Systemic sclerosis Diffuse cutaneous systemic sclerosis Scleroderma |
Biological Hyperimmune caprine serum Goat Serum |
|
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis |
Connective Tissue Diseases Skin Diseases Pathologic Processes |