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Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma Diseases

NCT03388255 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-09-16

No results posted yet for this study

Summary

This is a phase IV, single-arm, open-label clinical trial to evaluate the efficacy and safety of PLACENTEX ® Polydeoxyribonucleotide i.m. in patients with fibrotic and atrophic cutaneous lesions in scleroderma diseases during the inactive stage of the disease (experiencing dystrophic outcomes of the disease with no inflammatory component at the time of enrolment).

The patients enrolled will be evaluated at study site at screening (V1), then after 3 months of treatment with PLACENTEX ® Polydeoxyribonucleotide (one vial per day for intra-muscular administration) (V2). After completion of the study treatment period, the patients will be followed for an additional period of 3 months without study medication, after which the patient will visit the site for the last visit (V3). 1 investigational site. 45 patients enrolled (included drop-outs).3 months of treatment with PLACENTEX ® Polydeoxyribonucleotide (one vial per day for intra-muscular administration).

Conditions

  • Scleroderma Disease

Interventions

DRUG

Polydeoxyribonucleotides

Polydeoxyribonucleotide 5.625 mg/3 ml for parenteral use i.m. The study period consists of the following phases: * Treatment period: 3 months (daily i.m. treatment with PLACENTEX ® Polydeoxyribonucleotide 5.625 mg/3 ml for parenteral use, one vial per day for intra-muscular administration). * Follow up period: 3 months after end of active treatment, without study medication.

Sponsors & Collaborators

  • Sintesi Research Srl

    collaborator INDUSTRY

  • Mastelli S.r.l

    lead INDUSTRY

Principal Investigators

  • Simona Muratori, Dr · IRCCS Ca' Granda Osp. Maggiore Policlinico

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-08
Primary Completion
2019-10-30
Completion
2019-10-31

Countries

  • Italy

Study Locations

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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 NCT03388255 on ClinicalTrials.gov