Herpes ZosterPhase 3NCT05806918
Non-inferiority Study of ZK-A03 in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer
A Phase 3 study testing Recombinant Human Interferon α-2b Gel (After the Alteration) and Recombinant Human Interferon α-2b Gel (Before the Alteration) in people with Herpes Zoster, run by Lee's Pharmaceutical Limited.
Trial summary
The goal of this clinical trail is to demonstrate the non-inferiority of recombinant human interferon α-2b gel (ZK-A03) after changing the manufacturer of the active ingredient in patients with herpes zoster. This double-blind study will enroll approximately 368 adult patients with herpes zoster in China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Recombinant Human Interferon α-2b Gel (After the Alteration) and Recombinant Human Interferon α-2b Gel (Before the Alteration)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 30 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Men and women aged between 18 and 70 years old.
- Diagnosed as herpes zoster.
- Time to appearance of lesions ≤ 72 hours prior to the first dosing (lesions may represent as: erythema, papules or blisters), lesion area ≤ 3% body surface area (BSA).
- Self-rated Numerical Rating Scale (NRS) in pain ≤ 6.
- Negative serum pregnancy test for women of reproductive age. Birth control from first dosing until 1 month after last dosing for all men and women of reproductive age.
- Subjects must have signed an informed consent form (ICF).
Main Exclusion Criteria:
- Diagnosed as herpes zoster on face, visceral herpes zoster, herpes zoster meningitis, disseminated herpes zoster, zoster sine herpete or blood blisters and necrosis.
- The lesion is complicated with other skin diseases that may affect the evaluation of efficacy,
- Skin lesions combined with severe bacterial or fungal infections.
- Use of antiviral or analgesic therapy for herpes zoster within 2 weeks prior to the first dosing.
- Known allergies to recombinant human interferon α-2b and chemical structure analogs, valaciclovir or history of any drug, food or other allergy.
- Liver and/or renal disfunction，ie. Alanine aminotransferase (ALT), Aspartate transaminase (AST) > 2 times of upper normal limit（ULN）; Creatinine Clearance Rate (CCR) < 50 L/min.
- Combined with immunodeficiency disease or require long-term glucocorticoid or immunosuppressive drugs.
- Combined with severe cardiovascular, respiratory, gastrointestinal or neurological disorders and remains unstable after treatment.
- History of psychiatric illness or inability to fully comply to the protocol.
- Use of another investigational product within 4 weeks prior to the first dosing.
- Pregnant or lactating women.
- Other conditions deemed by the investigator to be inappropriate for participation in this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Double-blind, Controlled, Non-inferiority Phase III Clinical Trial of Recombinant Human Interferon Alpha-2b Gel (ZK-A03) in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer
The goal of this clinical trail is to demonstrate the non-inferiority of recombinant human interferon α-2b gel (ZK-A03) after changing the manufacturer of the active ingredient in patients with herpes zoster.
This double-blind study will enroll approximately 368 adult patients with herpes zoster in China. Eligible patients will be assigned randomly at a 1:1 ratio.
For each patient who is included, treatment may last up to 10 days. During the study, subjects will be treated with recombinant human interferon α-2b gel (either before or after the alteration of the active ingredient manufacturer), at a frequency of four times a day, together with a background therapy of valaciclovir hydrochloride.
- Conditions
- Herpes Zoster
- Being tested
- Recombinant Human Interferon α-2b Gel (After the Alteration), Recombinant Human Interferon α-2b Gel (Before the Alteration)
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Interferon α-2b Gel (After the Alteration)Drug
Recombinant human interferon α-2b gel (after the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride.
Recombinant Human Interferon α-2b Gel (Before the Alteration)Drug
Recombinant human interferon α-2b gel (before the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Interferon α-2b Gel (After the Alteration) | Experimental | Not described Receives: Drug: Recombinant Human Interferon α-2b Gel (After the Alteration) |
| Recombinant Human Interferon α-2b Gel (Before the Alteration) | Active comparator | Not described Receives: Drug: Recombinant Human Interferon α-2b Gel (Before the Alteration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate at visit 4 (Day 7)
Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.
Measured: 7 Days
Secondary outcomes (5)
Clinical cure rate at visit 3 (Day 4), and visit 5 (Day 11)
Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.
Measured: 11 Days
Time to which new blisters stop appearing
The time from the first day of medication (D1) to the cessation of new blisters.
Measured: 11 Days
The time to beginning of crusting.
The time from the first day of medication (D1) to the beginning of crusting.
Measured: 11 Days
The time to which all blisters are crustosus.
The time from the first day of medication (D1) to the crustosus of all blisters.
Measured: 11 Days
The pain improvement rate at visit 4 (Day 7)
Pain change of ≥1 from baseline is considered as pain improvement.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806918
- Sponsor's protocol ID
- ZK-A03-LEES-2023-01
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Controlled, Non-inferiority Phase III Clinical Trial of Recombinant Human Interferon Alpha-2b Gel (ZK-A03) in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer
- ClinicalTrials.gov ID
- NCT05806918
- Acronym / sponsor ID
- ZK-A03-LEES-2023-01
- Conditions
- Herpes Zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trail is to demonstrate the non-inferiority of recombinant human interferon α-2b gel (ZK-A03) after changing the manufacturer of the active ingredient in patients with herpes zoster.
This double-blind study will enroll approximately 368 adult patients with herpes zoster in China. Eligible patients will be assigned randomly at a 1:1 ratio.
For each patient who is included, treatment may last up to 10 days. During the study, subjects will be treated with recombinant human interferon α-2b gel (either before or after the alteration of the active ingredient manufacturer), at a frequency of four times a day, together with a background therapy of valaciclovir hydrochloride.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Interferon α-2b Gel (After the Alteration) | Experimental | Drug: Recombinant Human Interferon α-2b Gel (After the Alteration) |
| Recombinant Human Interferon α-2b Gel (Before the Alteration) | Active comparator | Drug: Recombinant Human Interferon α-2b Gel (Before the Alteration) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Interferon α-2b Gel (After the Alteration)Recombinant human interferon α-2b gel (after the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride. | Drug | Recombinant Human Interferon α-2b Gel (After the Alteration) |
| Recombinant Human Interferon α-2b Gel (Before the Alteration)Recombinant human interferon α-2b gel (before the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride. | Drug | Recombinant Human Interferon α-2b Gel (Before the Alteration) |
Primary outcome
Clinical cure rate at visit 4 (Day 7)
Time frame: 7 Days
Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.
5 secondary outcomes
Clinical cure rate at visit 3 (Day 4), and visit 5 (Day 11)
Time frame: 11 Days
Time to which new blisters stop appearing
Time frame: 11 Days
The time to beginning of crusting.
Time frame: 11 Days
The time to which all blisters are crustosus.
Time frame: 11 Days
The pain improvement rate at visit 4 (Day 7)
Time frame: 7 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Human Interferon α-2b Gel (After the Alteration) and Recombinant Human Interferon α-2b Gel (Before the Alteration) in people with Herpes Zoster, run by Lee's Pharmaceutical Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinghua Xu, MD (021-52887781, xjhhsyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate at visit 4 (Day 7) (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.