Hepatitis C Virus (HCV)NCT04214028
A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus
An observational study of Hepatitis C Virus (HCV), run by AbbVie at 54 sites in Japan.
Trial summary
This study will assess the safety and effectiveness of Maviret (Glecaprevir plus Pibrentasvir (GLE/PIB)) in adolescent participants diagnosed with chronic hepatitis C (CHC) in a real world setting across clinical practice in Japan. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Hepatitis C Virus (HCV)
- How many people
- 50 participants
- Where
- 54 sitesJapan
- Study dates
- 26 Dec 2019to 1 Aug 2024
- Phase
- Observational
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants aged ≥ 12 to <18 years of age with chronic hepatitis C receiving Maviret in accordance with local label.
Who may be able to join
- Chronic Hepatitis C Virus (HCV) infection treated in daily practice with Maviret
- Enrolled after Maviret treatment begins
- Prior treatment with Maviret
Who cannot join
- None
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Japan54 sites
Hyogo Prefectural Amagasaki General Medical Center /ID# 239388
Amagasaki-shi, Hyōgo, 660-8550
Hyogo Prefectural Amagasaki General Medical Center /ID# 261350
Amagasaki-shi, Hyōgo, 660-8550
Chiba University Hospital /ID# 225889
Chiba, Chiba, 260-8677
Tokyo Metropolitan Children's Medical Center /ID# 258142
Fuchu-shi, Tokyo, 183-8561
Yamada Clinic /ID# 225909
Fujisawa-shi, Kanagawa, 251-0046
Kyushu University Hospital /ID# 261351
Fukuoka, Fukuoka, 812-8582
Gifu Municipal Hospital /ID# 225890
Gifu, Gifu, 500-8513
Tamakoshi Clinic /ID# 224113
Hamamatsu, Shizuoka, 335-0023
Hirosaki University Hospital /ID# 262654
Hirosaki-shi, Aomori, 036-8203
Okanami General Hospital /ID# 256995
Iga-shi, Mie-ken, 518-0121
Nara Hospital Kinki University Faculty of Medicine, /ID# 224609
Ikoma-shi, Nara, 630-0227
Saitama Medical University Hospital /ID# 258144
Iruma-gun, Saitama, 350-0495
Ise Red Cross Hospital /ID# 222018
Ise-shi, Mie-ken, 516-0008
Fujikawa Clinic /ID# 221135
Kanzaki-gun, Hyōgo, 679-2337
Kariya Toyota General Hospital /ID# 239046
Kariya-shi, Aichi-ken, 448-8505
Watanabe Clinic /ID# 261352
Kasaoka-shi, Okayama-ken, 714-0088
Hospital of the University of Occupational and Environmental Health, Japan /ID# 255088
Kitakyushu-shi, Fukuoka, 807-8556
Takano Kids Clinic /ID# 251656
Kobe, Hyōgo, 655-0004
Aoyama Clinic /ID# 261942
Koriyama-shi, Fukushima, 963-0534
Kumamoto Shinto General Hospital /ID# 223245
Kumamoto, Kumamoto, 862-8655
Kurume University Hospital /ID# 224112
Kurume-shi, Fukuoka, 830-0011
University Hospital Kyoto Prefectural University of Medicine /ID# 229599
Kyoto, Kyoto, 602-8566
Kyoto Shimogamo Hospital /ID# 233903
Kyoto, Kyoto, 6060866
Machida Clinic /ID# 238744
Maebashi, Gunma, 371-0232
Gunma University Hospital /ID# 231700
Maebashi, Gunma, 371-8511
Tsukada Clinic /ID# 255152
Maibara-shi, Shiga, 521-0072
Aizawa Hospital /ID# 223247
Matsumoto-shi, Nagano, 390-0814
Matsuyama Red Cross Hospital /ID# 239387
Matsuyama, Ehime, 790-8524
Kousei General Hospital /ID# 249395
Mihara-shi, Hiroshima, 7230014
Misawa Municipal Misawa Hospital /ID# 229544
Misawa-shi, Aomori, 033-0123
Meijo Hospital /ID# 250955
Nagoya, Aichi-ken, 460-0001
Nagoya University Hospital /ID# 226746
Nagoya, Aichi-ken, 466-8560
Nagoya City University Hospital /ID# 238745
Nagoya, Aichi-ken, 467-8602
Heartlife Hospital /ID# 249394
Nakagami-gun, Okinawa, 901-2417
Nakatsu Municipal Hospital /ID# 233390
Nakatsu-shi, Oita Prefecture, 871-0011
Japanese Red Cross Narita Hospital /ID# 261349
Narita-shi, Chiba, 286-8523
Oita Cardiovascular Hospital /ID# 239725
Ōita, 861-1104
Kitano Hospital /ID# 255150
Osaka, Osaka, 530-8480
Yumura Clinic /ID# 254478
Osaka, Osaka, 545-0021
National Hospital Organization Sagamihara National Hospital /ID# 221136
Sagamihara-shi, Kanagawa, 252-0392
Saitama Children's Medical Center /ID# 227633
Saitama-shi, Saitama, 330-8777
Miyagi Children's Hospital /ID# 258143
Sendai, Miyagi, 989-3126
National Center for Child Health and Development /ID# 225293
Setagaya-ku, Tokyo, 157-8535
Shikoku Central Hospital of the Mutual Aid /ID# 230273
Shikokuchūō, Ehime, 799-0101
Shirakawa Kosei General Hosp. /ID# 240816
Shirakawa-shi, Fukushima, 961-0005
Osaka University Hospital /ID# 256174
Suita-shi, Osaka, 565-0871
Heisei Hidaka Clinic /ID# 231758
Takasaki, Gunma, 370-0001
Mie University Hospital /ID# 233864
Tsu, Mie-ken, 514-8507
University of tsukuba Hospital /ID# 267373
Tsukuba, Ibaraki, 305-8576
Yamaguchi University Hospital /ID# 262655
Ube-shi, Yamaguchi, 755-8505
Shonai Hospital /ID# 232294
Yamagata, 9978515
Kawaguchi Clinic /ID# 226843
Yokohama, Kanagawa, 234-0054
Tottori University Hospital /ID# 227634
Yonago-shi, Tottori, 683-8504
Ishibashi Clinic /ID# 258148
Yonezawa-shi, Yamagata, 992-0046
About this study
Official title: Real World Evidence of the Safety and Clinical Practice Use of Maviret in Adolescents Patients Infected With Chronic Hepatitis C Virus (All Case Survey)
This study will assess the safety and effectiveness of Maviret (Glecaprevir plus Pibrentasvir (GLE/PIB)) in adolescent participants diagnosed with chronic hepatitis C (CHC) in a real world setting across clinical practice in Japan.
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV), Chronic Hepatitis C (CHC), Maviret, Mavyret
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Maviret Participants | Participants receiving glecaprevir plus pibrentasvir (GLE/PIB, other names: Maviret) as routine standard of care for HCV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Drug Reactions (ADRs)
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Measured: Up to approximately 36 weeks
Percentage of Participants with Adverse Drug Reactions (ADRs)
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Measured: Up to approximately 36 weeks
Number of Participants with Serious Adverse Events (SAEs)
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Measured: Up to approximately 36 weeks
Percentage of Participants with Serious Adverse Events (SAEs)
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Measured: Up to approximately 36 weeks
Secondary outcomes (4)
Percentage of participants achieving Sustained Virologic Response 12 (SVR12)
Defined as HCV Ribonucleic acid (RNA) not detected 12 weeks after the last dose of study drug.
Measured: At Week 12
Percentage of participants achieving Sustained Virologic Response (SVR)
SVR defined as HCV Ribonucleic acid (RNA) < Lower limit of quantification (LLOQ).
Measured: At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks)
Percentage of Participants with On-Treatment Virologic Failure (Breakthrough)
On-treatment virologic failure (breakthrough) defined as at least 1 documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value ≥ 50 IU/mL).
Measured: Up to approximately 36 weeks
Percentage of Participants with After-Treatment Virologic Failure (Relapse)
After-treatment virologic failure (relapse) is defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Measured: Up to approximately 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start26 Dec 2019
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus (HCV)Studies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214028
- Sponsor's protocol ID
- P19-620
- Status last verified
- Jul 2025
- First submitted
- 27 Dec 2019
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence of the Safety and Clinical Practice Use of Maviret in Adolescents Patients Infected With Chronic Hepatitis C Virus (All Case Survey)
- ClinicalTrials.gov ID
- NCT04214028
- Acronym / sponsor ID
- P19-620
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV), Chronic Hepatitis C (CHC), Maviret, Mavyret
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 30 Dec 2019 (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 study will assess the safety and effectiveness of Maviret (Glecaprevir plus Pibrentasvir (GLE/PIB)) in adolescent participants diagnosed with chronic hepatitis C (CHC) in a real world setting across clinical practice in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maviret Participants | – | –Participants receiving glecaprevir plus pibrentasvir (GLE/PIB, other names: Maviret) as routine standard of care for HCV. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants aged ≥ 12 to <18 years of age with chronic hepatitis C receiving Maviret in accordance with local label.
Key inclusion criteria (3 listed)
- Chronic Hepatitis C Virus (HCV) infection treated in daily practice with Maviret
- Enrolled after Maviret treatment begins
- Prior treatment with Maviret
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Adverse Drug Reactions (ADRs)
Time frame: Up to approximately 36 weeks
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Percentage of Participants with Adverse Drug Reactions (ADRs)
Time frame: Up to approximately 36 weeks
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to approximately 36 weeks
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: Up to approximately 36 weeks
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
4 secondary outcomes
Percentage of participants achieving Sustained Virologic Response 12 (SVR12)
Time frame: At Week 12
Percentage of participants achieving Sustained Virologic Response (SVR)
Time frame: At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks)
Percentage of Participants with On-Treatment Virologic Failure (Breakthrough)
Time frame: Up to approximately 36 weeks
Percentage of Participants with After-Treatment Virologic Failure (Relapse)
Time frame: Up to approximately 36 weeks
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 20 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
ABBVIE INC. study director
AbbVie
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus (HCV), run by AbbVie at 54 sites in Japan.
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 3 inclusion and 1 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Japan. 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.
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?
Number of Participants with Adverse Drug Reactions (ADRs) (time frame: Up to approximately 36 weeks). The study lists 4 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 20 Jul 2025.