CLINICAL TRIAL

Ribavirin (RBV) for Hepatitis

Recruiting · 18+ · All Sexes · San Diego, CA

This study is evaluating whether a fixed dose combination of glecaprevir/pibrentasvir is effective in treating acute hepatitis C.

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About the trial for Hepatitis

Eligible Conditions
Hepatitis C · Hepatitis C Infections · Hepatitis A · Hepatitis · Communicable Diseases · Human Immunodeficiency Virus (HIV) Infections · Infections · Virus Diseases

Treatment Groups

This trial involves 2 different treatments. Ribavirin (RBV) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Glecaprevir/Pibrentasvir (G/P)
DRUG
Ribavirin (RBV)
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribavirin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Hepatitis or one of the other 7 conditions listed above. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A person who has had hepatitis C virus (HCV) infection within the last 24 weeks is not allowed to participate in the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Weeks 1, 2, 4, 8, 12, 28
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Weeks 1, 2, 4, 8, 12, 28.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ribavirin (RBV) will improve 3 primary outcomes and 2 secondary outcomes in patients with Hepatitis. Measurement will happen over the course of From study entry to Week 4.

Number of participants who complete 4 weeks of treatment without discontinuation due to AEs
FROM STUDY ENTRY TO WEEK 4
Number of participants who complete 4 weeks of treatment without discontinuation due to AEs
Proportion of participants who experienced adverse events (AEs)
FROM STUDY TREATMENT INITIATION TO 4 WEEKS AFTER STUDY TREATMENT DISCONTINUATION (WEEK 8)
Study protocol required reporting of (1) AEs Grade greater than or equal to 2, (2) AEs that led to a change in study treatment regardless of grade and (3) AEs meeting ICH definition of SAE or Expedited AE (EAE) reporting requirement. DAIDS AE Grading Table (V2.1) and DAIDS EAE Manual (V2.0) are used.
Number of participants with HCV virologic failure
WEEKS 1, 2, 4
Virologic failure defined as failure to achieve unquantifiable HCV RNA and confirmed increase in HCV RNA greater than 1 log10 from on-treatment nadir
Proportion of participants with sustained virologic response at 12 weeks post-treatment (SVR12)
WEEK 16 (12 WEEKS POST TREATMENT)
SVR12 defined as achieving unquantifiable HCV RNA (less than the lower limit of quantification [LLOQ] target detected [TD] or target not detected [TND]) at study visit 12 weeks post treatment. If a participant does not have any HCV RNA measurements in this time period then the participant will be considered as SVR12 failure, unless there are preceding and subsequent HCV RNA measurements that are both LLOQ (either TD or TND).
Proportion of participants with HCV RNA less than LLOQ
WEEKS 1, 2, 4, 8, 12, 28
Proportion of participants with HCV RNA less than LLOQ (TD or TND)

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is hepatitis?

Hepatitis is caused by hepatitis viruses. Most often, it is caused by hepatitis A and other viral infections. Hepatitis B and C are commonly transmitted from mother to child during pregnancy, through blood transfusion or liver transplantation, and are usually harmless. When hepatitis B or C occurs in an individual with hepatitis A, the results of any subsequent pregnancy can be complicated by hepatitis A virus carrier state, which can result in an increased risk to the fetus. There are no specific symptoms of hepatitis A viral infections. However, most individuals will experience symptoms of fatigue, which is often the reason as to why they visit their GP. Infections can be diagnosed on blood tests and by looking at the person’s medical history.

Anonymous Patient Answer

What are the signs of hepatitis?

Liver inflammation is characterised by a range of symptoms, not all of which can be associated with hepatitis. However, even with an acutely ill child, the presentation of symptoms is often vague and non-specific. Therefore, the exclusion of viral infections is essential. When considering the diagnosis of acute viral hepatitis in children, an understanding of the symptoms of viral infections is necessary. Therefore, it is important to take into account the most recent literature.

Anonymous Patient Answer

What are common treatments for hepatitis?

Common treatments to hepatitis include medications, lifestyle changes and blood testing.\nWhat are common treatments for pain problems? question: How to use opioid medications: what are common treatments for pain problems? answer: Chronic pain, such as chronic back pain, is much more prevalent and is a more disabling condition than pain due to a sudden injury or a short-term health problem. Common treatments include nonsteroidal anti-inflammatory drugs (NSAIDs) and opioid products. The optimal duration of use, the greatest degree of relief and the best side effect profile vary based on the patient and the type of pain being experienced.

Anonymous Patient Answer

What causes hepatitis?

Hepatitis is caused by many different factors, and may result in liver cirrhosis and liver failure. Alcohol, or drugs, which damage the liver, are among the factors that can cause hepatitis. Infection with hepatitis E causes liver inflammation, jaundice, and sometimes liver failure. Hepatitis B and hepatitis C can cause either chronic or acute infection. In many people, the infection is latent. For people with chronic hepatitis, cirrhosis may occur, though most do not realize a underlying liver disease. In those with acute infection, the infection is usually self-limiting.

Anonymous Patient Answer

How many people get hepatitis a year in the United States?

In the United States, yearly cases of acute hepatitis A have been about 7 000 since 1977, with two peaks in 1994 at 5 000 cases and in 1999 of 7 000 cases per million. Annual cases peaked at 40000 in 2009 with a total of 50000 cases. The number of hepatitis B cases has been increasing steadily, but in 2009 reached 1230 000. Cases of hepatitis B virus in 2009 numbered 26 000, of which 93 % were accounted by children (10-15 years). The incidence of chronic hepatitis B has decreased annually by more than 90 % from 1990 to 2009-2011–2012, to just 1500–2000 per year (1.2 % of population). The age-adjusted prevalence increased from 0.

Anonymous Patient Answer

Can hepatitis be cured?

Hepatitis cannot usually be cured. Liver biopsies are necessary (to make sure the disease does not progress). The disease does not usually progress in the first 4 weeks because of the excellent compliance achieved with treatment. In most cases, the disease is best treated by giving interferon and ribavirin for one or two years, which results in a sustained, good response.

Anonymous Patient Answer

What does ribavirin (rbv) usually treat?

The data presented in this study suggest that rbv does not significantly reduce the viral load or the number of circulating virions in patients with HCV. In a recent study, findings exclude the use of rbv for the treatment of HCV-related acute decompensation.

Anonymous Patient Answer

How serious can hepatitis be?

Patients' most important concerns regarding hepatitis are related to liver-related health problems, including liver cancer, bleeding, and bruising. Knowledge alone of the risk of serious liver complications to HCV infection is insufficient for patient management, and interventions are needed to improve patient comprehension of the risk for liver disease.

Anonymous Patient Answer

What are the common side effects of ribavirin (rbv)?

The majority of people are admitted to the ICU for the development of viral infections and liver failure. Rbv-related side effects that are serious usually develop within hours of starting the medication. Side effects range from mild to life-threatening. They can be very severe and sometimes life-threatening if they occur. Signs and symptoms vary depending on the type of virus that is causing infection and the immune system status of the person taking rbv. Serious side effects include pneumonitis, hepatitis of acute or chronic type, thyroid disorder, nervous system, eye, skin, and hair problems, and psychiatric disorders. All people should report severe or life-threatening side effects to their doctor. If more information is needed, go to www.

Anonymous Patient Answer

What is the latest research for hepatitis?

In this overview, we have identified a new study for the treatment of hepatitis C, which is in the stage of early clinical research (2017). In conclusion, there are many ongoing clinical studies to determine the effectiveness of Hepatitis C treatment in order to improve patients' outcomes.

Anonymous Patient Answer

Have there been other clinical trials involving ribavirin (rbv)?

Although there are a few placebo-controlled studies on RBV as treatment or prophylaxis for chronic hepatitis C, these studies are too limited in size for general conclusions, but more trials are needed to determine better the role of RBV for chronic hepatitis C patients.

Anonymous Patient Answer

Does hepatitis run in families?

Hepatitis B transmission from parents to their children seems to be an occupational hazard. However, there is no epidemiologic evidence for an HCV specific family pattern. Results from a recent clinical trial support the hypothesis that HCV does not always cross the family line.

Anonymous Patient Answer
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