A Phase 2/3 interventional study of Sofosbuvir and Daclatasvir in Hepatitis C, Chronic, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 2/3, Interventional, and Treatment
Among 83 studies testing peginterferon alfa-2a in Hepatitis C, Chronic — none open to participants now, none under way, none of them phase 3. peginterferon alfa-2a · Hepatitis C, Chronic.
Among the 83 studies testing peginterferon alfa-2a in Hepatitis C, Chronic, this one is the 38th largest by enrollment, is the only one that started in 2018, is the only one in phase 2/3, and was the 82nd registered.
950 studies on the registry are indexed under Hepatitis C, Chronic; 8 are open to participants now.
This study's enrollment of 150 is above the median of 90 across 696 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →None of the 83 studies testing peginterferon alfa-2a in Hepatitis C, Chronic is open now.
peginterferon alfa-2a: first FDA approval 2002 (PEGASYS), first EMA approval 2002. What it is approved for, and how studies give it, is on its page →
Of the 5 Hepatitis C, Chronic studies recruiting now, 2 (40%) set no upper age limit and 2 (40%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →83 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2018.
Median enrollment 129 across the 83 interventional studies. Of the 75 that completed or were terminated, 38 (51%) have results posted.
44 of 83 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Johns Hopkins Bloomberg School of Public Health has 2 studies filed under Hepatitis C, Chronic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 83 studies testing peginterferon alfa-2a in Hepatitis C, Chronic, from their registry updates:
Nothing recorded among them since 2026-09-25.
The primary objective of this pilot trial is to compare the efficacy, measured as sustained virologic response (SVR) at least 12 weeks after completion of therapy, across three study regimens/delivery modalities: Arm 1 - 4 weeks of sofosbuvir (SOF) + daclatasvir (DAC) + pegylated interferon alfa-2a (PEG) delivered using directly observed therapy (DOT); Arm 2 - 12 weeks of SOF+DAC delivered using DOT; and Arm 3 - 12 weeks of SOF+DAC delivered as per standard of care (monthly dispensation with no DOT). Secondary objectives are 1)To compare the cost per SVR for each of the three study arms; 2) To compare adherence among persons across the three study arms; 3) To evaluate the safety, tolerability and acceptability of treatment in the three arms.
This will be a non-blinded randomized clinical trial with 150 participants randomized at a 1:1:1 allocation ratio to one of three treatment arms.
Arm 1: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach
Arm 2: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach
Arm 3: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)
Pegylated-interferon alfa-2a (PEG) will be delivered subcutaneously once weekly. Sofosbuvir (SOF) and Daclatasvir (DAC) will be taken orally once daily for the entire study period.
The study will take place at the YR Gaitonde Centre for AIDS Education (YRG) and Johns Hopkins University (JHU) Collaborative Integrated Care Center (YRG-JHU ICC) located within the premises of the Chattisgarh Institute of Medical Sciences (CIMS) in Bilaspur in the state of Chattisgarh, India.
Participants will be recruited from the YRG-JHU ICC in Bilaspur, which currently has 514 registered HCV antibody positive clients. The Bilaspur ICC is in the Chattisgarh Institute for Medical Sciences (CIMS).
The primary outcome will be sustained virologic response (SVR12). Secondary outcomes include cost per SVR12, adherence, safety and tolerability.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must have the following laboratory parameters at screening:
A female subject is eligible to enroll in the study if it is confirmed that she is:
Of childbearing potential (i.e., women who have not had a hysterectomy, both ovaries removed or medically documented ovarian failure). [NOTE: Women ≤50 years of age with amenorrhea will be considered to be of childbearing potential.] These women must have a negative urine pregnancy test at screening and a negative urine pregnancy test on the Baseline /Day 1 visit prior to randomization and agree to one of the following modes of for the duration of treatment and 12 weeks thereafter.
or
i. Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from 3 weeks prior to Baseline/Day 1 until the end of treatment. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone containing contraceptive prior to screening may continue their contraceptive regimen in addition to the study specified methods of birth control.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach
Drug: Sofosbuvir · Drug: Daclatasvir · Drug: Pegylated Interferon alfa-2a
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach
Drug: Sofosbuvir · Drug: Daclatasvir
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)
Drug: Sofosbuvir · Drug: Daclatasvir
Direct acting antiviral agent used for the treatment of hepatitis C
Also known as: Sovaldi, Hepcvir, MyHep, Hepcinat, Resof, SoviHep
Direct acting antiviral agent used for the treatment of hepatitis C
Also known as: Daklinza, Natdac, Daclahep, Dacihep, Hepdac, Mydekla
Antiviral agent used for the treatment of hepatitis C
Also known as: Pegasys, Taspiance
SVR12
Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion
Time frame: 12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC
Serious Adverse Events
Number of participants with treatment-related serious adverse events by laboratory tests and physician examination
Time frame: 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC
Medication Adherence
Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence
Time frame: 4 weeks for SOF+DAC+PEG and 12 weeks for SOF+DAC
| Milestone | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard |
|---|---|---|---|
| Started | 50 | 50 | 50 |
| Completed | 47 | 45 | 45 |
| Not completed | 3 | 5 | 5 |
| Withdrew: Death | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 | 3 |
| Withdrew: Incarcerated | 2 | 2 | 2 |
Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion
| Participants | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard |
|---|---|---|---|
| SVR12 | 26 | 30 | 17 |
Number of participants with treatment-related serious adverse events by laboratory tests and physician examination
| Participants | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard |
|---|---|---|---|
| Serious Adverse Events | 0 | 0 | 0 |
Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence
| Participants | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard |
|---|---|---|---|
| Medication Adherence | 35 | 31 | 10 |
Collected over 16 weeks for Arm 1 and 24 weeks for ARms 2 and 3. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SOF+DAC+PEG | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| SOF+DAC, DOT | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| SOF+DAC, Standard | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard | Total |
|---|---|---|---|---|
| Median | 25 (21 to 31) | 26 (22 to 31) | 25 (21 to 30) | 25 (22 to 30) |
| Sex: Female, Male(Participants) | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 50 | 50 | 50 | 150 |
| Race/Ethnicity, Customized(Participants) | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard | Total |
|---|---|---|---|---|
| Indian | 50 | 50 | 50 | 150 |
| Region of Enrollment(participants) | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard | Total |
|---|---|---|---|---|
| India | 50 | 50 | 50 | 150 |
| Educational attainment(Participants) | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard | Total |
|---|---|---|---|---|
| None | 3 | 2 | 6 | 11 |
| Primary school | 19 | 16 | 15 | 50 |
| Secondary school | 9 | 20 | 17 | 46 |
| At least high school | 19 | 12 | 12 | 43 |
| Employment(Participants) | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard | Total |
|---|---|---|---|---|
| Monthly wages | 19 | 16 | 12 | 47 |
| Weekly wages | 5 | 8 | 3 | 16 |
| Daily wages | 22 | 25 | 28 | 75 |
| Unemployment | 3 | 1 | 7 | 11 |
| Missing | 1 | 0 | 0 | 1 |
| Marital status(Participants) | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard | Total |
|---|---|---|---|---|
| Never married | 31 | 32 | 30 | 93 |
| Currently married | 15 | 13 | 17 | 45 |
| Separated | 0 | 1 | 0 | 1 |
| Living with partner | 4 | 4 | 3 | 11 |
| Injection drug use frequency in prior month(Participants) | SOF+DAC+PEG | SOF+DAC, DOT | SOF+DAC, Standard | Total |
|---|---|---|---|---|
| None | 3 | 5 | 4 | 12 |
| Once a week to less than twice a week | 24 | 17 | 22 | 63 |
| Twice a week to six times a week | 15 | 15 | 18 | 48 |
| Daily | 8 | 13 | 6 | 27 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Peginterferon alfa-2a
Johns Hopkins Bloomberg School of Public Health →