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AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis

NCT00769028 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-08-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Hyperimmune caprine serum

Subcutaneous injection of serum, 1ml twice weekly for 6 months

DRUG

Albumin

Subcutaneous injection of albumin, 1ml twice weekly for 6 months

Sponsors & Collaborators

  • Daval International Limited

    lead INDUSTRY

Principal Investigators

  • Christopher P Denton, PhD FRCP · Royal Free Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-02-28
Completion
2011-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769028 on ClinicalTrials.gov