Herpes ZosterPhase 2NCT05492591
A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster
A Phase 2 study testing Peginterferon α1b, Peginterferon α1b with valacyclovir and Valacyclovir in people with Herpes Zoster, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
To evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections of peginterferon α1b in patients with herpes zoster, and provide support for phase III clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Peginterferon α1b, Peginterferon α1b with valacyclovir and Valacyclovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2022to 22 Jul 2023
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must give informed consent to the study and agree to participate and give written consent before the study;
- 18 Years to 75 Years （Including 18 and 75 years old），Male or Female;
- Pain VAS score≥3;
- Patients with clinical diagnosis of Herpes Zoster，According to the Chinese Expert Consensus on Herpes zoster (2018) (the rash was asymmetric, unilateral erythematous or maculopapular rash, or clusters of small blisters could appear, and the blister fluid was clear or became cloudy), the appearance of herpes zoster was determined within 3 days (72 hours).
Who cannot join
- Allergic constitution or history of allergy or known allergy to the test drug product or any component;
- Clinically diagnosed as herpes zoster without rash, disseminated herpes zoster; ear herpes zoster; ocular herpes zoster; with symptoms of viral encephalitis and meningitis; with symptoms of acute gastroenteritis and cystitis; Herpes zoster patients with hemorrhagic, gangrenous clinical manifestations, etc;
- Herpes site with neuralgia caused by other diseases;
- History of serious heart disease, including unstable or uncontrolled angina within 6 months, history of myocardial infarction and other heart disease, epilepsy and other central nervous system disorders, history of autoimmune hepatitis or autoimmune disease, severe liver function Impaired or decompensated cirrhosis, severe mental illness or medical history;
- During the screening period, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 fold ULN;Platelet count <90×109/L;Hemoglobin: male<110g/L，female<100g/L;White blood cell count <3.5×109/L、neutrophil count <1.5×109/L;Renal insufficiency（Cr>1.5 fold ULN and creatinine clearance <60 mL/min），abnormal thyroid function test, positive hepatitis B surface antigen, positive hepatitis C antibody, positive treponema pallidum antibody or positive HIV antibody test in serum virology;
- Previous history of psoriasis;
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- Previous organ transplant recipients;
- Patients with active hemorrhagic disease, or severe hematopoietic abnormalities or coagulation disorders within 2 weeks prior to screening;
- Patients with previous history of malignant tumor;
- Patients with a history of severe retinal disease;
- Have received live attenuated vaccine (hepatitis B vaccine, pneumonia vaccine, tetanus vaccine, rabies virus vaccine, cervical cancer vaccine, etc.) within 3 months before screening or planned to receive live attenuated vaccine (hepatitis B vaccine, pneumonia vaccine, tetanus vaccine, rabies virus vaccine, cervical cancer vaccine, etc.) during the trial; have received COVID-19 vaccine within 2 weeks before screening or planned to receive COVID-19 vaccine during the trial;
- Lactating women, blood pregnancy positive subjects (female subjects only), male subjects (or their partners) or female subjects had pregnancy plans or sperm or egg donation plans from 30 days before the study to 3 months after the end of the study and were unwilling to take effective contraceptive measures;
- Participated in any drug or device clinical investigator within 3 months prior to screening;
- Need for driving or precision instrument operation during the study period;
- Within 1 month or 5 half-lives (whichever is the longest) before screening, drugs with therapeutic effect on herpes zoster have been systematically used: interferon, antiviral drugs, immune modulators, glucocorticoids, traditional Chinese medicine/patent medicine, neurotrophic drugs, drugs containing theophylline, etc;
- The patients who had been treated with topical drugs for herpes zoster within 2 weeks before the screening were selected;
- The investigators considered it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences Dermatology Hospital
Nanjing, Jiangsu
About this study
Official title: A Multicenter, Randomized, Active-controlled, Dose-finding Phase II Clinical Study Evaluating the Safety and Efficacy of Peginterferon α1b for Injection in Patients With Herpes Zoster
To evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections of peginterferon α1b in patients with herpes zoster, and provide support for phase III clinical trials.
Read the detailed description
This trial is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study. A total of 5 experimental groups and 1 positive drug control group were set up to evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections of peginterferon α1b in patients with herpes zoster, and provide support for phase III clinical trials.
- Conditions
- Herpes Zoster
- Being tested
- Peginterferon α1b, Peginterferon α1b with valacyclovir, Valacyclovir
- Keywords
- Herpes zoster, peginterferon, efficacy, safety, postherpetic neuralgia
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon α1bDrug
Injecting different doses of the peginterferon α1b into different groups of subjects.
Peginterferon α1b with valacyclovirDrug
Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.
ValacyclovirDrug
Valacyclovir is a positive control drug.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 5 μg/kg of peginterferon α1b for injection in patients with herpes zoster. Receives: Drug: Peginterferon α1b |
| Group 2 | Experimental | 6 μg/kg of peginterferon α1b for injection in patients with herpes zoster. Receives: Drug: Peginterferon α1b |
| Group 3 | Experimental | 7 μg/kg of peginterferon α1b for injection in patients with herpes zoster. Receives: Drug: Peginterferon α1b |
| Group 4 | Experimental | Both valacyclovir tablets and 6 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster. Receives: Drug: Peginterferon α1b with valacyclovir |
| Group 5 | Experimental | Both valacyclovir tablets and 7 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster. Receives: Drug: Peginterferon α1b with valacyclovir |
| Group 6 | Active comparator | Only valacyclovir tablets in patients with herpes zoster, positive drug control group. Receives: Drug: Valacyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of stop increasing new blisters/pimples
The number of days it took for the herpes to stop increasing (the original blisters/pimples enlarge, and the blisters/pimples increase) after the subjects were screened and enrolled.
Measured: 5 days after the first dose
Time of target herpes begins to scab
The time taken for the target herpes (where the herpes first occurred when the patient was enrolled) begin to scab after the subjects were screened for enrollment.
Measured: 7 days after the first dose.
Time of complete scabbing of all herpes
The time taken for all the herpes to be completely crusted (the blisters have dried up and crusted) after the subjects were screened and enrolled.
Measured: 10 days after the first dose.
Secondary outcomes (14)
Changes in VAS scores on day 1 from baseline
Changes in VAS scores of subjects on day 1 from baseline.
Measured: 1 days after the first dose.
Changes in VAS scores on day 2 from baseline
Changes in VAS scores of subjects on day 2 from baseline.
Measured: 2 days after the first dose.
Changes in VAS scores on day 3 from baseline
Changes in VAS scores of subjects on day 3 from baseline.
Measured: 3 days after the first dose.
Changes in VAS scores on day 4 from baseline
Changes in VAS scores of subjects on day 4 from baseline.
Measured: 4 days after the first dose.
Changes in VAS scores on day 6 from baseline
Changes in VAS scores of subjects on day 6 from baseline.
Measured: 6 days after the first dose.
Changes in VAS scores on day 10 from baseline
Changes in VAS scores of subjects on day 10 from baseline.
Measured: 10 days after the first dose.
Changes in VAS scores on day 14 from baseline
Changes in VAS scores of subjects on day 14 from baseline.
Measured: 14 days after the first dose.
Changes in VAS scores on day 21 from baseline
Changes in VAS scores of subjects on day 21 from baseline.
Measured: 21 days after the first dose.
Changes in VAS scores on day 27 from baseline
Changes in VAS scores of subjects on day 27 from baseline.
Measured: 27 days after the first dose.
Time that VAS score to drop to ≤2
The time taken for the VAS score to decrease from baseline ≥3 to ≤2 for the first time after the subjects were screened and enrolled.
Measured: 10 days after the first dose.
Duration time that VAS score to drop to ≤2
After the subject's VAS score dropped from baseline ≥ 3 to ≤ 2 for the first time, the time that the VAS score remained at ≤ 2.
Measured: 20 days after the first dose.
The time that scabs of blisters fall off
The number of days it took for the scabs of all herpes to completely fall off after the subjects were screened into the group.
Measured: 16 days after the first dose.
Dose of painkiller
The dose of painkiller used within 27 days of the subject's first dose.
Measured: 16 days after the first dose.
Incidence of postherpetic neuralgia
The incidence of hereditary neuralgia within 105 days after the first dose of the subjects. Postherpetic neuralgia is defined as pain lasting one month or more after the rash has healed (ie, complete exfoliation).
Measured: 105 days after the first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start11 Oct 2022
- Primary completion22 Jul 2023
- Study completion22 Jul 2023
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.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qianjin Lu, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492591
- Sponsor's protocol ID
- SIBP-R01
- Status last verified
- Dec 2023
- First submitted
- 5 Aug 2022
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Active-controlled, Dose-finding Phase II Clinical Study Evaluating the Safety and Efficacy of Peginterferon α1b for Injection in Patients With Herpes Zoster
- ClinicalTrials.gov ID
- NCT05492591
- Acronym / sponsor ID
- SIBP-R01
- Conditions
- Herpes Zoster
- Keywords
- Herpes zoster, peginterferon, efficacy, safety, postherpetic neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 8 Aug 2022 (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.
To evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections of peginterferon α1b in patients with herpes zoster, and provide support for phase III clinical trials.
Detailed description
This trial is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study. A total of 5 experimental groups and 1 positive drug control group were set up to evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections of peginterferon α1b in patients with herpes zoster, and provide support for phase III clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- This is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Peginterferon α1b5 μg/kg of peginterferon α1b for injection in patients with herpes zoster. |
| Group 2 | Experimental | Drug: Peginterferon α1b6 μg/kg of peginterferon α1b for injection in patients with herpes zoster. |
| Group 3 | Experimental | Drug: Peginterferon α1b7 μg/kg of peginterferon α1b for injection in patients with herpes zoster. |
| Group 4 | Experimental | Drug: Peginterferon α1b with valacyclovirBoth valacyclovir tablets and 6 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster. |
| Group 5 | Experimental | Drug: Peginterferon α1b with valacyclovirBoth valacyclovir tablets and 7 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster. |
| Group 6 | Active comparator | Drug: ValacyclovirOnly valacyclovir tablets in patients with herpes zoster, positive drug control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must give informed consent to the study and agree to participate and give written consent before the study;
- 18 Years to 75 Years （Including 18 and 75 years old），Male or Female;
- Pain VAS score≥3;
- Patients with clinical diagnosis of Herpes Zoster，According to the Chinese Expert Consensus on Herpes zoster (2018) (the rash was asymmetric, unilateral erythematous or maculopapular rash, or clusters of small blisters could appear, and the blister fluid was clear or became cloudy), the appearance of herpes zoster was determined within 3 days (72 hours).
Key exclusion criteria (17 listed)
- Allergic constitution or history of allergy or known allergy to the test drug product or any component;
- Clinically diagnosed as herpes zoster without rash, disseminated herpes zoster; ear herpes zoster; ocular herpes zoster; with symptoms of viral encephalitis and meningitis; with symptoms of acute gastroenteritis and cystitis; Herpes zoster patients with hemorrhagic, gangrenous clinical manifestations, etc;
- Herpes site with neuralgia caused by other diseases;
- History of serious heart disease, including unstable or uncontrolled angina within 6 months, history of myocardial infarction and other heart disease, epilepsy and other central nervous system disorders, history of autoimmune hepatitis or autoimmune disease, severe liver function Impaired or decompensated cirrhosis, severe mental illness or medical history;
- During the screening period, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 fold ULN;Platelet count <90×109/L;Hemoglobin: male<110g/L，female<100g/L;White blood cell count <3.5×109/L、neutrophil count <1.5×109/L;Renal insufficiency（Cr>1.5 fold ULN and creatinine clearance <60 mL/min），abnormal thyroid function test, positive hepatitis B surface antigen, positive hepatitis C antibody, positive treponema pallidum antibody or positive HIV antibody test in serum virology;
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 |
|---|---|---|
| Peginterferon α1bInjecting different doses of the peginterferon α1b into different groups of subjects. | Drug | Group 1, Group 2, Group 3 |
| Peginterferon α1b with valacyclovirBoth valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects. | Drug | Group 4, Group 5 |
| ValacyclovirValacyclovir is a positive control drug. | Drug | Group 6 |
Primary outcome
Time of stop increasing new blisters/pimples
Time frame: 5 days after the first dose
The number of days it took for the herpes to stop increasing (the original blisters/pimples enlarge, and the blisters/pimples increase) after the subjects were screened and enrolled.
Time of target herpes begins to scab
Time frame: 7 days after the first dose.
The time taken for the target herpes (where the herpes first occurred when the patient was enrolled) begin to scab after the subjects were screened for enrollment.
Time of complete scabbing of all herpes
Time frame: 10 days after the first dose.
The time taken for all the herpes to be completely crusted (the blisters have dried up and crusted) after the subjects were screened and enrolled.
14 secondary outcomes
Changes in VAS scores on day 1 from baseline
Time frame: 1 days after the first dose.
Changes in VAS scores on day 2 from baseline
Time frame: 2 days after the first dose.
Changes in VAS scores on day 3 from baseline
Time frame: 3 days after the first dose.
Changes in VAS scores on day 4 from baseline
Time frame: 4 days after the first dose.
Changes in VAS scores on day 6 from baseline
Time frame: 6 days after the first dose.
Changes in VAS scores on day 10 from baseline
Time frame: 10 days after the first dose.
Changes in VAS scores on day 14 from baseline
Time frame: 14 days after the first dose.
Changes in VAS scores on day 21 from baseline
Time frame: 21 days after the first dose.
Changes in VAS scores on day 27 from baseline
Time frame: 27 days after the first dose.
Time that VAS score to drop to ≤2
Time frame: 10 days after the first dose.
Duration time that VAS score to drop to ≤2
Time frame: 20 days after the first dose.
The time that scabs of blisters fall off
Time frame: 16 days after the first dose.
Dose of painkiller
Time frame: 16 days after the first dose.
Incidence of postherpetic neuralgia
Time frame: 105 days after the first dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 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.
Qianjin Lu principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peginterferon α1b, Peginterferon α1b with valacyclovir and Valacyclovir in people with Herpes Zoster, run by Shanghai Institute Of Biological Products at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. 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: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of stop increasing new blisters/pimples (time frame: 5 days after the first dose). The study lists 3 primary outcomes in all. 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 29 Dec 2023.