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Chloropyramine Hydrochloride

This article discusses a phase III clinical trial investigating the use of ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs) for treating epidermolysis bullosa (EB), a rare genetic skin condition. The trial aims to evaluate the safety and efficacy of this treatment in patients with recessive dystrophic epidermolysis bullosa (RDEB) and junctional epidermolysis bullosa (JEB).

Table of Contents

What is Chloropyramine Hydrochloride?

Chloropyramine Hydrochloride is a medication that belongs to a class of drugs known as antihistamines[1]. Antihistamines work by blocking the effects of histamine, a substance in the body that causes allergic symptoms. The medication is marketed under the brand name Synopen, specifically as “Synopen 20 mg/2 ml otopina za injekciju,” which translates to “Synopen 20 mg/2 ml solution for injection” in English[1].

Medical Uses

While the specific medical uses are not explicitly stated in the provided clinical trial data, antihistamines like Chloropyramine Hydrochloride are typically used to treat various allergic conditions. These may include:

  • Allergic rhinitis (hay fever)
  • Urticaria (hives)
  • Allergic skin reactions
  • Itching associated with various conditions

It’s important to note that the exact indications may vary depending on the country and specific formulation[1].

How is it Administered?

Chloropyramine Hydrochloride, in the form mentioned in the clinical trial data, is administered intravenously. This means it is given directly into a vein[1]. Intravenous administration allows the medication to enter the bloodstream quickly, which can be beneficial in situations requiring rapid relief of symptoms.

Dosage Information

According to the clinical trial data, the maximum daily dose of Chloropyramine Hydrochloride is 0.2 mg/kg (milligrams per kilogram of body weight)[1]. This means the dose is adjusted based on the patient’s weight. For example, a person weighing 70 kg (about 154 pounds) would receive a maximum daily dose of 14 mg.

The maximum treatment period mentioned in the data is 11 time units, though the specific unit (days, weeks, etc.) is not specified[1]. Always follow your healthcare provider’s instructions regarding dosage and duration of treatment.

Current Clinical Trial

It’s important to note that Chloropyramine Hydrochloride is mentioned as part of a clinical trial for a different treatment. The main focus of this trial is not on Chloropyramine Hydrochloride itself, but on a cell therapy for a rare skin condition called epidermolysis bullosa[1]. Chloropyramine Hydrochloride is likely included as a supportive medication in this trial, possibly to manage allergic reactions or itching associated with the condition or treatment.

Important Considerations

When using Chloropyramine Hydrochloride or any medication, keep the following in mind:

  • Prescription requirement: This medication is likely to be available only by prescription and should be used under medical supervision.
  • Potential side effects: As with all medications, Chloropyramine Hydrochloride may cause side effects. Common side effects of antihistamines can include drowsiness, dry mouth, and blurred vision.
  • Drug interactions: Inform your healthcare provider about all medications you’re taking, as antihistamines can interact with various drugs.
  • Special populations: The use of this medication in pregnant women, breastfeeding mothers, children, and elderly patients may require special consideration.

Always consult with your healthcare provider for personalized advice and information about Chloropyramine Hydrochloride or any other medication[1].

Aspect Details
Trial Type Phase III, double-blind, randomized, placebo-controlled, interventional, multicenter
Condition Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional Epidermolysis Bullosa (JEB)
Intervention ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs)
Primary Endpoint Proportion of RDEB subjects ≥ 1 year with complete target wound closure at Month 6
Key Secondary Endpoints Changes in overall wound burden, pain severity, itch severity, quality of life
Safety Assessments Anti-HLA antibody levels, T-cell analysis, adverse events, physical examination, laboratory parameters
Duration Assessments up to Month 17, main analysis at Month 6b

FAQ

  • What is the main goal of this clinical trial? The main goal is to investigate the safety and efficacy of ABCB5+ MSCs administered intravenously to patients with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo. The trial also includes an open-label arm for patients with junctional epidermolysis bullosa (JEB) and RDEB patients under 1 year old.
  • Who can participate in this clinical trial? Participants must be diagnosed with RDEB or JEB, confirmed by genetic testing or skin biopsy. They must weigh at least 5 kg and meet specific health criteria, including having a target wound between 5-50 cm² that is less than 9 months old and shows no signs of acute infection.
  • What are some of the exclusion criteria for this trial? Exclusion criteria include a history of skin precancerous or cancerous lesions, known chronic lung disease, thromboembolic events, immunoreactions, allergies to the investigational product components, pregnancy or lactation, and participation in other clinical trials within 30 days of screening.
  • What are the primary and secondary endpoints of the trial? The primary endpoint is the proportion of RDEB subjects ≥ 1 year with complete target wound closure at Month 6. Secondary endpoints include changes in overall wound burden, pain severity, itch severity, quality of life, and various safety assessments.
  • How long does the trial last? The trial includes assessments up to Month 17, with the main analysis using data obtained until Month 6b. Safety endpoints will be monitored throughout the study period.

Ongoing Clinical Trials on Chloropyramine Hydrochloride

  • Study on ABCB5+ MSCs for Recessive Dystrophic and Junctional Epidermolysis Bullosa Patients

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Croatia Denmark France Germany Greece +6

Glossary

  • Epidermolysis bullosa (EB): A group of rare genetic skin conditions that cause fragile skin that blisters and tears easily.
  • ABCB5+ MSCs: ABCB5-positive mesenchymal stromal cells, which are the investigational treatment being studied in this trial for EB.
  • Recessive Dystrophic Epidermolysis Bullosa (RDEB): A severe form of EB caused by mutations in the COL7A1 gene, leading to extremely fragile skin.
  • Junctional Epidermolysis Bullosa (JEB): Another form of EB caused by mutations in genes coding for proteins in the skin's basement membrane.
  • Immunofluorescence mapping (IFM): A diagnostic technique used to identify the location of skin separation in EB patients.
  • Anti-Human Leukocyte Antigen (Anti-HLA) antibodies: Antibodies that can develop against foreign human cells, used to assess immunogenicity in this trial.
  • EBDASI: Epidermolysis Bullosa Disease Activity and Scarring Index, a tool used to measure disease activity and damage in EB patients.
  • CDLQI: Children's Dermatology Life Quality Index, a questionnaire used to assess quality of life in children with skin conditions.

References

  1. http://clinicaltrials.eu/trial/36922/