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Specific Nucleic Acid Sna-Her2

A new clinical trial is underway to assess the effectiveness of 2LHERP®, a medication containing Specific Nucleic Acid SNA-HER2, in treating recurrent orofacial herpes infections, commonly known as cold sores. This randomized, placebo-controlled, double-blind study aims to determine if 2LHERP® can reduce the frequency and severity of cold sore outbreaks in patients who experience frequent episodes.

Table of Contents

What is 2LHERP?

2LHERP is a medication designed to treat recurrent cold sores, also known as orofacial herpes infections. It comes in the form of granules in capsules that are meant to be opened before use[1]. The medication contains several active ingredients, including:

  • Deoxyribonucleic acid (DNA): The genetic material found in all living organisms
  • Ribonucleic acid (RNA): A molecule similar to DNA that plays various roles in biological processes
  • Specific Nucleic Acid SNA-HER1: Also known as SNA-HER1 or Specific Nucleic Acid – Herpes Simplex Type I Virus
  • Specific Nucleic Acid SNA-HER2: Also known as SNA-HER2 or Specific Nucleic Acid – Herpes Simplex Type II Virus
  • Specific Nucleic Acid SNA-HLA I: Also known as SNA-HLA I or Specific Nucleic Acid – Human Leucocyte Antigen Type I
  • Specific Nucleic Acid SNA-HLA II: Also known as SNA-HLA II or Specific Nucleic Acid – Human Leucocyte Antigen Type II

What Conditions Does 2LHERP Treat?

2LHERP is specifically designed to treat recurrent orofacial herpes infections, commonly known as cold sores or fever blisters[1]. These are painful, fluid-filled blisters that typically appear around the mouth or on the lips. They are caused by the herpes simplex virus (HSV), usually type 1 (HSV-1) or occasionally type 2 (HSV-2).

The medication is intended for patients who experience frequent outbreaks, specifically those who have had 6 or more episodes within a 12-month period[1].

How 2LHERP Works

While the exact mechanism of action is not fully explained in the provided information, 2LHERP appears to work by utilizing specific nucleic acids that target the herpes simplex virus and interact with the human immune system[1]. The inclusion of SNA-HER1 and SNA-HER2 suggests that the medication is designed to address both HSV-1 and HSV-2 infections. The SNA-HLA I and SNA-HLA II components likely interact with the body’s immune system, as HLA (Human Leukocyte Antigen) plays a crucial role in immune responses.

Clinical Trial Details

A clinical trial is being conducted to evaluate the effectiveness of 2LHERP[1]. Here are some key details about the study:

  • It is a Phase IV clinical trial, which means the medication is already marketed but is being further studied
  • The study is randomized, placebo-controlled, and double-blind, ensuring reliable results
  • The main objective is to evaluate how well 2LHERP reduces the number of recurrent cold sore episodes over a 12-month period
  • Secondary objectives include comparing 2LHERP to a placebo in terms of:
    • Number of episodes at 6 months
    • Time to the first episode during treatment
    • Duration of episodes
    • Symptoms during relapses
    • Use of rescue medication
    • Impact on quality of life
    • Safety issues

Eligibility Criteria

To participate in the clinical trial, patients must meet certain criteria[1]:

Inclusion Criteria:

  • Age: 16-80 years old
  • History of 6 or more cold sore episodes in the past 12 months
  • Women of childbearing age must use effective contraception
  • Participants must be in a stable sexual relationship
  • Ability to understand and follow study requirements
  • Willingness to sign an informed consent form

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patients on immunotherapy or who have received microimmunotherapy in the last 6 months
  • Those who have used suppressive antiviral therapy in the last month or wish to continue such therapy
  • Known lactose intolerance
  • Recent participation in other clinical studies (within the last 3 months)
  • Inability to commit to a 12-month follow-up period
  • Severe immunodeficiency diseases, ongoing chemotherapy, radiotherapy, or corticosteroid therapy
  • Use of certain homeopathic or herbal treatments
  • Use of or addiction to recreational drugs

Expected Outcomes

The primary goal of the study is to measure the change in the number of cold sore episodes over 12 months compared to the baseline (number of episodes in the 12 months before starting treatment)[1]. Secondary outcomes being measured include:

  • Remaining free from cold sores for 6 and 12 months after starting treatment
  • Time until the first cold sore outbreak during treatment
  • Average duration of cold sore episodes
  • Pain levels during outbreaks
  • Need for additional (rescue) medication
  • Impact on quality of life
  • Occurrence of adverse events (side effects)

Potential Benefits

If proven effective, 2LHERP could offer several benefits to patients with recurrent cold sores[1]:

  • Reduced frequency of cold sore outbreaks
  • Shorter duration of cold sore episodes
  • Less severe symptoms during outbreaks
  • Improved quality of life
  • Potentially fewer side effects compared to traditional antiviral medications (this would need to be confirmed by the study results)

Administration and Dosage

2LHERP is administered orally (by mouth) as granules in capsules that are meant to be opened before use[1]. The maximum daily dose is 380 mg, with a maximum total dose of 68.4 g over the course of treatment. The treatment period can last up to 6 months.

It’s important to note that these dosage details are based on the clinical trial information and may not reflect the final recommended dosage if the medication is approved for general use. Always follow the instructions provided by your healthcare provider when taking any medication.

Aspect Details
Study Design Randomized, placebo-controlled, double-blind
Medication 2LHERP® (containing Specific Nucleic Acid SNA-HER2)
Primary Objective Reduce number of recurrent orofacial herpes episodes at 12 months
Secondary Objectives Evaluate episodes at 6 months, time to first episode, duration, symptoms, rescue medication use, quality of life, safety
Participant Age Range 16-80 years
Inclusion Criteria 6+ episodes in previous 12 months, stable sexual relationship, effective contraception for women
Exclusion Criteria Pregnancy, immunotherapy, recent suppressive antiviral therapy, lactose intolerance, severe immunodeficiency
Treatment Duration 12 months
Dosage Form Granules in capsules to be opened
Maximum Daily Dose 380 mg

FAQ

  • What is the main goal of this clinical trial? The main goal is to evaluate how effective 2LHERP® is in reducing the number of recurrent orofacial herpes (cold sore) episodes over a 12-month period.
  • Who can participate in this study? The study is open to men and women aged 16-80 years who have experienced 6 or more episodes of orofacial herpes infections in the 12 months before joining the study.
  • How long does the clinical trial last? The trial lasts for 12 months, during which participants will be monitored for cold sore outbreaks and other related factors.
  • What will be measured during the study? The study will measure the number of cold sore episodes, time to first recurrence, duration of episodes, pain levels, use of rescue medication, quality of life, and any side effects.
  • What is 2LHERP® and how is it administered? 2LHERP® is a medication containing specific nucleic acids, including SNA-HER2. It comes in the form of granules in capsules that are to be opened and taken orally (through the mouth).

Ongoing Clinical Trials on Specific Nucleic Acid Sna-Her2

  • Study on the Effectiveness of 2LHERP in Reducing Recurrent Cold Sores in Patients with Frequent Outbreaks

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Orofacial herpes: A viral infection caused by the herpes simplex virus that affects the face, particularly the mouth and lips, resulting in cold sores or fever blisters.
  • Placebo-controlled: A study design where some participants receive an inactive substance (placebo) instead of the actual medication, allowing researchers to compare the true effects of the drug being tested.
  • Double-blind: A study method where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving the placebo, reducing potential bias in the results.
  • Specific Nucleic Acid SNA-HER2: A type of nucleic acid that targets the herpes simplex virus type II, which is one of the active ingredients in 2LHERP®.
  • Rescue Medication: Additional medication that participants are allowed to use if they experience severe symptoms during the study.
  • Immunotherapy: A type of treatment that uses the body's immune system to fight diseases, including viral infections.
  • Suppressive antiviral therapy: A treatment approach where antiviral medications are taken regularly to prevent or reduce the frequency of viral outbreaks.
  • Adverse Events (AEs): Any unfavorable or unintended sign, symptom, or disease that occurs during the study, whether or not it is related to the treatment.
  • Serious Adverse Events (SAEs): Adverse events that result in death, are life-threatening, require hospitalization, or cause significant disability.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-2lherp-in-reducing-recurrent-cold-sores-in-patients-with-frequent-outbreaks/