HerpanginaPhase 4NCT03266601
Effect of Recombinant Human Interferon α-2b Spray on Herpangina
A Phase 4 study testing Recombinant Human Interferon α-2b Spray and Ribavirin in people with Herpangina, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric patients with herpangina. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Herpangina
- What is being tested?
- Recombinant Human Interferon α-2b Spray and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 31 Dec 2018
- Phase
- Phase 4
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects should meet all of the following:
- meet the diagnostic criteria for pediatric herpangina;
- ages 1-7 years, no limitation for gender;
- within 72 hours of onset;
- the main organs (heart, liver, kidney and lung) function normally;
- follow up according to requirements and be hospitalized for observation;
- the guardian is fully informed and signed informed consent.
Who cannot join
- Subjects should be excluded if meet any of the following:
- have allergy history of interferon;
- heart failure, respiratory insufficiency,liver and kidney dysfunction or severe malnutrition and other serious disease, or immunodeficient;
- children with epilepsy or other neurological disorders;
- other pathogens exist at the same time;
- the researchers believe that it is not appropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients
This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric patients with herpangina.
- Conditions
- Herpangina
- Being tested
- Recombinant Human Interferon α-2b Spray, Ribavirin
- Keywords
- Aged 1-7 years old, within 72 hours of onset patients with herpangina
- Medical subject headings
- Herpangina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Interferon α-2b SprayDrug
Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).
RibavirinDrug
Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Interferon α-2b Spray | Experimental | Not described Receives: Drug: Recombinant Human Interferon α-2b Spray |
| Ribavirin | Active comparator | Not described Receives: Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The defervesce rate during treatment by 72 hours
Body temperature returned to normal,and remain at least 24 hours.
Measured: Measure the body temperature every 4 hours from starting of treatment to the 96th hour.
Secondary outcomes (9)
Abnormal blood routine
White blood cell count, absolute neutrophil count, absolute lymphocyte count, platelet count, hemoglobin, the five indicators if one is abnormal, abnormal blood routine is defined as "1", if five indicators all are normal, abnormal blood routine is defined as "0".
Measured: Before admission and 72th hours after treatment.
The significant efficiency rate
Within 48 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers significantly improved and no new appeared, appetite significantly improved.
Measured: From starting of treatment to the 48th hour.
The effective rate
Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved.
Measured: From starting of treatment to the 72th hour.
The ineffective rate
After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty.
Measured: From starting of treatment to the 96th hour.
The total effective rate
Total effective rate = efficiency rate + effective rate.
Measured: From starting of treatment to the 96th hour.
Total hospital stay
Measured: From starting of treatment to the 96th hour.
Appetite improvement
Measured: From starting of treatment to the 96th hour.
Myocardial enzymes and electrocardiogram
Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal.
Measured: Before admission and 72th hours after treatment.
The condition of herpes and ulcers subside
Clinical examination to check herpes subsided, ulcer wounds smaller, with or
Measured: Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Jun 2016
- Primary completion30 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerpanginaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Sinobioway Biomedicine Co.Ltd., Hunan Children's Hospital, Children's Hospital of Chongqing Medical University, Yuying Children's Hospital of Wenzhou Medical University, Qilu Children's Hospital of Shandong University, Children's Hospital of Kaifeng City, Shenzhen Children's Hospital, Zunyi Medical College, Changhai Hospital, Anhui Provincial Children's Hospital
- Responsible party
- Principal investigator, Hui Yu, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266601
- Sponsor's protocol ID
- AFL-2015-2.0
- Status last verified
- Mar 2019
- First submitted
- 10 Aug 2017
- Last updated
- 7 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03266601
- Acronym / sponsor ID
- AFL-2015-2.0
- Conditions
- Herpangina
- Keywords
- Aged 1-7 years old, within 72 hours of onset patients with herpangina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Tianjin Sinobioway Biomedicine Co.Ltd., Hunan Children's Hospital, Children's Hospital of Chongqing Medical University, Yuying Children's Hospital of Wenzhou Medical University, Qilu Children's Hospital of Shandong University, Children's Hospital of Kaifeng City, Shenzhen Children's Hospital, Zunyi Medical College, Changhai Hospital, Anhui Provincial Children's Hospital
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Aug 2017 (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.
This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric patients with herpangina.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Interferon α-2b Spray | Experimental | Drug: Recombinant Human Interferon α-2b Spray |
| Ribavirin | Active comparator | Drug: Ribavirin |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- meet the diagnostic criteria for pediatric herpangina;
- ages 1-7 years, no limitation for gender;
- within 72 hours of onset;
- the main organs (heart, liver, kidney and lung) function normally;
- follow up according to requirements and be hospitalized for observation;
Key exclusion criteria (6 listed)
- have allergy history of interferon;
- heart failure, respiratory insufficiency,liver and kidney dysfunction or severe malnutrition and other serious disease, or immunodeficient;
- children with epilepsy or other neurological disorders;
- other pathogens exist at the same time;
- the researchers believe that it is not appropriate to participate in this study.
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 SprayRecombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour). | Drug | Recombinant Human Interferon α-2b Spray |
| RibavirinRibavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ). | Drug | Ribavirin |
Primary outcome
The defervesce rate during treatment by 72 hours
Time frame: Measure the body temperature every 4 hours from starting of treatment to the 96th hour.
Body temperature returned to normal,and remain at least 24 hours.
9 secondary outcomes
Abnormal blood routine
Time frame: Before admission and 72th hours after treatment.
The significant efficiency rate
Time frame: From starting of treatment to the 48th hour.
The effective rate
Time frame: From starting of treatment to the 72th hour.
The ineffective rate
Time frame: From starting of treatment to the 96th hour.
The total effective rate
Time frame: From starting of treatment to the 96th hour.
Total hospital stay
Time frame: From starting of treatment to the 96th hour.
Appetite improvement
Time frame: From starting of treatment to the 96th hour.
Myocardial enzymes and electrocardiogram
Time frame: Before admission and 72th hours after treatment.
The condition of herpes and ulcers subside
Time frame: Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour.
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 7 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Human Interferon α-2b Spray and Ribavirin in people with Herpangina, run by Children's Hospital of Fudan University 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 7 inclusion and 6 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 7 Mar 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The defervesce rate during treatment by 72 hours (time frame: Measure the body temperature every 4 hours from starting of treatment to the 96th hour.). 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 7 Mar 2019.